Arrow International LLC
3015 Carrington Mill Blvd.
Morrisville, NC 27560
May-2023

URGENT MEDICAL DEVICE RECALL
Type of Action
Teleflex Reference
Product Code & Batch/Lot Number
Commercial Name

Arrow Endurance™ Extended Dwell
Peripheral Catheter System

Recall Notice
EIF-000538
Refer to Appendix 2
Product Codes

ASK-00620-MSH
ASK-00818-IVA
EDC-00620
EDC-00622-B
EDC-00820
EDC-00822-B

ASK-00620-TMC
ASK-00820-FLH
EDC-00620-B
EDC-00818
EDC-00820-B

ASK-00622-MSH
ASK-00820-TMC
EDC-00622
EDC-00818-B
EDC-00822

Dear Customer,
Details of affected devices
Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary recall for theabove listed products; refer to Appendix 2 for Unique Device Identifier (“UDI”) and lot number
information.
Description of the problem & immediate actions required
This voluntary recall has been initiated due to reports of catheter separation or leakage. If the catheter
separates while in venous or arterial use, the catheter fragments could be left inside the patient’s
bloodstream, where they may migrate. This could possibly lead to serious adverse healthconsequences such as blockage of blood vessels, ischemia, injury to blood vessel walls, developmentof blood clots, pulmonary embolism, heart attack or death. Some situations may require medical or
surgical intervention.
Between May 2018 and May 2023, Teleflex received 83 complaints reporting separations and leakage.
No deaths or long-term patient injuries have been reported at this time.
For current indwelling devices, Teleflex recommends that clinical staff weigh the benefits versus risksof removing and replacing the device.
Our records indicate you have received products that are subject to this recall.

Page 1 of 10

Depending on your device location please adhere to the following Action list:
Device location
Action List Number
Medical facilities (hospitals, medical staff, etc.)
1
Distributors
2
Action list number 1 – Medical facilities
1. We request that you immediately check your inventory for product within the scope of thisrecall. Users should immediately cease use and distribution of affected product andimmediately quarantine the affected product.
2. If you have affected product, mark the applicable checkbox on the Acknowledgement Form
(Appendix 1) and fax it to 1-855-419-8507, including “Attn: Customer Service”, or e-mail it torecalls@teleflex.com. This will allow us to document the amount of affected product you haveon hand for return. A customer service representative will contact you with a Return Goods
Authorization (RGA) number and will provide instructions for the return of affected products
to Teleflex.
3. If you do not have affected product, mark the applicable checkbox on the Acknowledgement
Form (Appendix 1) and return the form to Teleflex at the contact details provided.
4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected
product.
Action list number 2 – Distributors
1. Provide a copy of this recall notice to all customers who have received impacted product. Eachof your customers is then required to complete the Acknowledgement Form and return it toyou.
2. We request that you immediately check your inventory for affected product. Immediately
cease use and distribution of, and immediately quarantine, the affected product. You may
then return all product in scope.
3. As a distributor, you are then required to confirm to Teleflex that you have completed thefield activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of youractions, please forward the completed Acknowledgement Form to the e-mail address below.
Important - Please ensure you only list batch numbers in scope of this recall notice whencompleting this form.
4. If you have further distributed product outside of your country, please notify Teleflex
Customer Service by return e-mail to the e-mail address below.
Adverse reactions or quality problems experienced with the use of this product should be reported toTeleflex Customer Service using the contact information below or may also be reported to the FDA’s
MedWatch Adverse Event Reporting program either by phone at 1-888-INFO-FDA (1-888-463-6332) or
onlineathttps://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-eventreporting-program.
Transmission of this Field Safety NoticeThis notice should be passed on to all persons who need to be aware within your organization or toany organization where the potentially affected devices have been transferred.

Page 2 of 10

Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc., in thecirculation of this notice. Please maintain awareness of this notice until all required actions have been
completed in your organization.
Contact reference person
Should you require further information or support concerning this issue, please contact Customer
Service via email, phone, or FAX using the details provided below. Customer Service hours of operation
are 8am–7pm EST.
Customer Service:
Contact: Customer Service
FAX: 1-855-419-8507

Telephone: 1-866-396-2111
Email: Recalls@teleflex.com

Teleflex is committed to providing high quality, safe and effective products. We regret any
inconvenience this action may cause your operations. If you have any other questions, please contact
your local Teleflex sales representative or Teleflex Customer Service.

For and on behalf of Teleflex,

Padraig Hegarty
Padraig Hegarty VP, Global QA (Manufacturing)

Page 3 of 10

Appendix 1

RECALLACKNOWLEDGEMENT FORM

Consignee No____________________________MEDICAL DEVICE RECALL BY TELEFLEX – IMMEDIATE ATTENTION REQUIRED
Ref. EIF-000538
RETURN COMPLETED FORM IMMEDIATELY TO:
E-mail: Recalls@teleflex.com☐ We confirm receipt of this recall ☐ We confirm receipt of this recall notice and completion of thenotice and completion of the required
actions contained therein. We further
confirm that our inventory does NOT
include products impacted by thisrecall.

required actions contained therein. We further confirm ourinventory DOES include products impacted by this recall. The use
and further distribution of the affected products is stopped. All
products are put on hold and the amount below will be returned.

Complete this Acknowledgement Form and return the completed form immediately using thecontact information above.
Quantity returning
Product code
Lot/batch number
Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form.

•Include a copy of the completed Acknowledgement Form in the returns package with the returned units•Please label returns as “Field Safety Returns”

INSTITUTION NAME (E.G., NAME OF HOSPITAL, HEALTH CARE ORGANIZATION)

INSTITUTION ADDRESSPHONE/FAX

FORM COMPLETED BY

E-MAILPRINT NAME: ___________________________
SIGNATURE: ___________________________
DATE

Page 4 of 10

Appendix 2: Product in scope of EIF-000538

Product CodeASK-00620-MSH
ASK-00620-MSH
ASK-00620-TMC
ASK-00620-TMC
ASK-00620-TMC
ASK-00620-TMC
ASK-00620-TMC
ASK-00620-TMC
ASK-00620-TMC
ASK-00622-MSH
ASK-00622-MSH
ASK-00818-IVA
ASK-00818-IVA
ASK-00820-FLH
ASK-00820-FLH
ASK-00820-FLH
ASK-00820-FLH
ASK-00820-FLH
ASK-00820-FLH
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
ASK-00820-TMC
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620

Batch
13F22H0910
13F22L0492
13F21J0257
13F22E0014
13F22E0263
13F22G0191
13F22K0352
13F23A0220
33F23B1020
13F22H0912
13F22L0361
13F21L0242
13F22C0480
13F22A0808
13F22E0250
13F22F0034
13F22K1112
13F22L0530
33F23B1019
13F22B0679
13F22C0817
13F22E0442
13F22F0601
13F22J0341
13F22K1113
13F22L0266
13F22L0910
33F23B1025
14F18H0260
14F18H0451
14F18K0137
14F18L0078
14F18M0028
14F21E0292
14F21F0075
14F21F0129
14F21F0250
14F21G0240
14F21H0189
14F21H0220
14F21J0112
14F21J0169
14F21K0030

Unique Device Identifier (UDI)(01)10801902212105 (17)240630 (11)220914 (10)13F22H0910(01)10801902212105 (17)240630 (11)221118 (10)13F22L0492(01)10801902193022 (17)230531 (10)13F21J0257(01)10801902193022 (17)230731 (11)220511 (10)13F22E0014(01)10801902193022 (17)230731 (11)220527 (10)13F22E0263(01)10801902193022 (17)240229 (11)220729 (10)13F22G0191(01)10801902193022 (17)240430 (11)221012 (10)13F22K0352(01)10801902193022 (17)240430 (11)230113 (10)13F23A0220(01)10801902193022 (17)240731 (11)230309 (10)33F23B1020(01)10801902212112 (17)240630 (11)220909 (10)13F22H0912(01)10801902212112 (17)240630 (11)221114 (10)13F22L0361(01)10801902144499 (17)231031 (10)13F21L0242(01)10801902144499 (17)240229 (11)220324 (10)13F22C0480(01)10801902146318 (17)230630 (11)220124 (10)13F22A0808(01)10801902146318 (17)230930 (11)220530 (10)13F22E0250(01)10801902146318 (17)231231 (11)220606 (10)13F22F0034(01)10801902146318 (17)240331 (11)221107 (10)13F22K1112(01)10801902146318 (17)240331 (11)221122 (10)13F22L0530(01)10801902146318 (17)240831 (11)230309 (10)33F23B1019(01)10801902192988 (17)230731 (11)220309 (10)13F22B0679(01)10801902192988 (17)230731 (11)220412 (10)13F22C0817(01)10801902192988 (17)230731 (11)220527 (10)13F22E0442(01)10801902192988 (17)230731 (11)220715 (10)13F22F0601(01)10801902192988 (17)240229 (11)220924 (10)13F22J0341(01)10801902192988 (17)240430 (11)221107 (10)13F22K1113(01)10801902192988 (17)240430 (11)221114 (10)13F22L0266(01)10801902192988 (17)240430 (11)221206 (10)13F22L0910(01)10801902192988 (17)240731 (11)230309 (10)33F23B1025(01)10801902132908 (17)230831 (10)14F18H0260(01)10801902132908 (17)230831 (10)14F18H0451(01)10801902132908 (17)200930 (10)14F18K0137(01)10801902132908 (17)231031 (10)14F18L0078(01)10801902132908 (17)201130 (10)14F18M0028(01)10801902132908 (17)230531 (10)14F21E0292(01)10801902132908 (17)230531 (10)14F21F0075(01)10801902132908 (17)230531 (10)14F21F0129(01)10801902132908 (17)230731 (10)14F21F0250(01)10801902132908 (17)230731 (10)14F21G0240(01)10801902132908 (17)230731 (10)14F21H0189(01)10801902132908 (17)230831 (10)14F21H0220(01)10801902132908 (17)230831 (10)14F21J0112(01)10801902132908 (17)230930 (10)14F21J0169(01)10801902132908 (17)230930 (10)14F21K0030
Page 5 of 10

Appendix 2: Product in scope of EIF-000538

Product Code
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620
EDC-00620-B
EDC-00620-B

Batch
14F21K0053
14F21L0209
14F21L0210
14F21L0211
14F21M0098
14F21M0099
14F22A0008
14F22C0097
14F22C0098
14F22C0099
14F22C0100
14F22C0270
14F22C0271
14F22C0272
14F22D0083
14F22D0084
14F22E0009
14F22E0068
14F22E0125
14F22F0071
14F22F0333
14F22G0051
14F22G0052
14F22G0217
14F22G0218
14F22H0342
14F22J0279
14F22K0061
14F22K0210
14F22L0027
14F22L0028
14F22L0070
14F22L0071
14F22L0161
14F23A0058
14F23A0174
14F23A0175
14F23A0176
14F23A0177
14F23A0308
14F23B0201
13F21E0852
13F21F0212

Unique Device Identifier (UDI)(01)10801902132908 (17)230930 (10)14F21K0053(01)10801902132908 (17)231031 (10)14F21L0209(01)10801902132908 (17)231031 (10)14F21L0210(01)10801902132908 (17)231031 (10)14F21L0211(01)10801902196368 (17)231231 (10)14F21M0098(01)10801902196368 (17)231231 (10)14F21M0099(01)10801902196368 (17)231231 (10)14F22A0008(01)10801902196368 (17)240229 (10)14F22C0097(01)10801902196368 (17)240229 (10)14F22C0098(01)10801902196368 (17)240229 (10)14F22C0099(01)10801902196368 (17)240229 (10)14F22C0100(01)10801902196368 (17)240229 (10)14F22C0270(01)10801902196368 (17)240331 (10)14F22C0271(01)10801902196368 (17)240331 (10)14F22C0272(01)10801902196368 (17)240331 (10)14F22D0083(01)10801902196368 (17)240331 (10)14F22D0084(01)10801902196368 (17)240430 (10)14F22E0009(01)10801902196368 (17)240430 (10)14F22E0068(01)10801902132908 (17)240430 (10)14F22E0125(01)10801902196368 (17)240531 (10)14F22F0071(01)10801902196368 (17)240630 (10)14F22F0333(01)10801902196368 (17)240630 (10)14F22G0051(01)10801902196368 (17)240630 (10)14F22G0052(01)10801902196368 (17)240731 (10)14F22G0217(01)10801902196368 (17)240731 (10)14F22G0218(01)10801902196368 (17)240831 (10)14F22H0342(01)10801902196368 (17)240930 (10)14F22J0279(01)10801902196368 (17)240930 (10)14F22K0061(01)10801902196368 (17)241031 (10)14F22K0210(01)10801902196368 (17)241031 (10)14F22L0027(01)10801902196368 (17)241031 (10)14F22L0028(01)10801902196368 (17)241031 (10)14F22L0070(01)10801902196368 (17)241031 (10)14F22L0071(01)10801902196368 (17)241130 (10)14F22L0161(01)10801902196368 (17)241231 (10)14F23A0058(01)10801902196368 (17)241231 (10)14F23A0174(01)10801902196368 (17)241231 (10)14F23A0175(01)10801902196368 (17)241231 (10)14F23A0176(01)10801902196368 (17)241231 (10)14F23A0177(01)10801902196368 (17)241231 (10)14F23A0308(01)10801902196368 (17)250131 (10)14F23B0201(01)10801902133004 (17)230531 (10)13F21E0852(01)10801902133004 (17)230531 (10)13F21F0212
Page 6 of 10

Appendix 2: Product in scope of EIF-000538

Product Code
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00620-B
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622
EDC-00622-B
EDC-00622-B
EDC-00622-B
EDC-00622-B
EDC-00622-B
EDC-00622-B
EDC-00818
EDC-00818

Batch
13F21F0523
13F21G1197
13F21H1179
13F21J0282
13F21K0896
13F21M0122
13F22A0152
13F22B0677
13F22E0261
13F22G0196
13F22K0354
13F22K0563
13F22M0126
13F22M0468
33F23B1021
14F21D0276
14F21F0151
14F21G0117
14F21G0286
14F21H0218
14F21J0111
14F21K0051
14F21L0212
14F21L0218
14F21M0101
14F22A0055
14F22C0101
14F22E0008
14F22F0152
14F22G0219
14F22G0243
14F22J0148
14F22K0211
14F22M0119
14F23A0072
13F21J0635
13F22E0264
13F22J0565
13F22K1119
13F22M0124
13F22M0459
14F21F0077
14F21G0241

Unique Device Identifier (UDI)(01)10801902133004 (17)230531 (10)13F21F0523(01)10801902133004 (17)230630 (10)13F21G1197(01)10801902133004 (17)230831 (10)13F21H1179(01)10801902133004 (17)230831 (10)13F21J0282(01)10801902133004 (17)230930 (10)13F21K0896(01)10801902133004 (17)231130 (10)13F21M0122(01)10801902133004 (17)231231 (10)13F22A0152(01)10801902133004 (17)240229 (10)13F22B0677(01)10801902133004 (17)240430 (10)13F22E0261(01)10801902133004 (17)240630 (10)13F22G0196(01)10801902133004 (17)240930 (10)13F22K0354(01)10801902133004 (17)240930 (10)13F22K0563(01)10801902133004 (17)241130 (11)221214 (10)13F22M0126(01)10801902133004 (17)241231 (11)230105 (10)13F22M0468(01)10801902133004 (17)250228 (11)230310 (10)33F23B1021(01)10801902132922 (17)230531 (10)14F21D0276(01)10801902132922 (17)230531 (10)14F21F0151(01)10801902132922 (17)230630 (10)14F21G0117(01)10801902132922 (17)230731 (10)14F21G0286(01)10801902132922 (17)230831 (10)14F21H0218(01)10801902132922 (17)230831 (10)14F21J0111(01)10801902132922 (17)230930 (10)14F21K0051(01)10801902132922 (17)231130 (10)14F21L0212(01)10801902132922 (17)231130 (10)14F21L0218(01)10801902196375 (17)231231 (10)14F21M0101(01)10801902196375 (17)231231 (10)14F22A0055(01)10801902196375 (17)240229 (10)14F22C0101(01)10801902196375 (17)240430 (10)14F22E0008(01)10801902196375 (17)240531 (10)14F22F0152(01)10801902196375 (17)240731 (10)14F22G0219(01)10801902196375 (17)240731 (10)14F22G0243(01)10801902196375 (17)240831 (10)14F22J0148(01)10801902196375 (17)241031 (10)14F22K0211(01)10801902196375 (17)241130 (10)14F22M0119(01)10801902196375 (17)241231 (10)14F23A0072(01)10801902133028 (17)230831 (10)13F21J0635(01)10801902133028 (17)240430 (10)13F22E0264(01)10801902133028 (17)240831 (11)220928 (10)13F22J0565(01)10801902133028 (17)241031 (11)221103 (10)13F22K1119(01)10801902133028 (17)241130 (11)221214 (10)13F22M0124(01)10801902133028 (17)241130 (11)230102 (10)13F22M0459(01)10801902132946 (17)230531 (10)14F21F0077(01)10801902132946 (17)230731 (10)14F21G0241
Page 7 of 10

Appendix 2: Product in scope of EIF-000538

Product Code
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00818-B
EDC-00820
EDC-00820
EDC-00820

Batch
14F21H0187
14F21H0219
14F21J0110
14F21J0170
14F21K0054
14F21L0213
14F21L0214
14F21L0219
14F22A0189
14F22A0190
14F22C0102
14F22C0103
14F22C0104
14F22D0101
14F22E0010
14F22F0005
14F22F0006
14F22F0089
14F22G0123
14F22H0344
14F22J0208
14F22K0128
14F22K0129
14F22K0212
14F22K0213
14F23A0180
14F23A0309
14F23B0330
13F21F1022
13F21J0283
13F21K0047
13F21L0653
13F21M0598
13F22C0492
13F22E0440
13F22J0572
13F22K0681
13F22L0279
13F22M0125
33F23B1023
14F18H0447
14F21E0293
14F21F0076

Unique Device Identifier (UDI)(01)10801902132946 (17)230731 (10)14F21H0187(01)10801902132946 (17)230831 (10)14F21H0219(01)10801902132946 (17)230831 (10)14F21J0110(01)10801902132946 (17)231031 (10)14F21J0170(01)10801902132946 (17)230930 (10)14F21K0054(01)10801902132946 (17)231130 (10)14F21L0213(01)10801902132946 (17)231130 (10)14F21L0214(01)10801902132946 (17)231130 (10)14F21L0219(01)10801902196382 (17)231231 (10)14F22A0189(01)10801902196382 (17)231231 (10)14F22A0190(01)10801902196382 (17)240229 (10)14F22C0102(01)10801902196382 (17)240229 (10)14F22C0103(01)10801902196382 (17)240229 (10)14F22C0104(01)10801902196382 (17)240331 (10)14F22D0101(01)10801902196382 (17)240430 (10)14F22E0010(01)10801902132946 (17)240531 (10)14F22F0005(01)10801902196382 (17)240531 (10)14F22F0006(01)10801902196382 (17)240531 (10)14F22F0089(01)10801902196382 (17)240630 (10)14F22G0123(01)10801902196382 (17)240831 (10)14F22H0344(01)10801902196382 (17)240831 (10)14F22J0208(01)10801902196382 (17)240930 (10)14F22K0128(01)10801902196382 (17)240930 (10)14F22K0129(01)10801902196382 (17)241031 (10)14F22K0212(01)10801902196382 (17)241031 (10)14F22K0213(01)10801902196382 (17)241231 (10)14F23A0180(01)10801902196382 (17)241231 (10)14F23A0309(01)10801902196382 (17)250228 (10)14F23B0330(01)10801902133042 (17)230531 (10)13F21F1022(01)10801902133042 (17)230831 (10)13F21J0283(01)10801902133042 (17)230930 (10)13F21K0047(01)10801902133042 (17)231031 (10)13F21L0563(01)10801902133042 (17)231231 (10)13F21M0598(01)10801902133042 (17)240229 (10)13F22C0492(01)10801902133042 (17)240430 (10)13F22E0440(01)10801902133042 (17)240831 (11)220923 (10)13F22J0572(01)10801902133042 (17)240930 (11)221021 (10)13F22K0681(01)10801902133042 (17)241031 (11)221114 (10)13F22L0279(01)10801902133042 (17)241130 (11)221213 (10)13F22M0125(01)10801902133042 (17)250228 (11)230309 (10)33F23B1023(01)10801902132960 (17)230831 (10)14F18H0447(01)10801902132960 (17)230531 (10)14F21E0293(01)10801902132960 (17)230531 (10)14F21F0076
Page 8 of 10

Appendix 2: Product in scope of EIF-000538

Product Code
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820
EDC-00820-B
EDC-00820-B
EDC-00820-B

Batch
14F21F0253
14F21G0239
14F21J0114
14F21J0372
14F21K0052
14F21L0138
14F21L0139
14F21L0215
14F21L0216
14F21L0220
14F21M0014
14F22C0105
14F22C0106
14F22C0107
14F22C0108
14F22C0109
14F22C0110
14F22D0085
14F22D0086
14F22D0087
14F22E0114
14F22E0117
14F22F0008
14F22F0090
14F22G0124
14F22G0125
14F22H0345
14F22K0030
14F22K0159
14F22K0222
14F22L0072
14F22M0039
14F22M0040
14F22M0117
14F22M0118
14F23A0178
14F23A0310
14F23A0311
14F23B0326
14F23B0327
13F21E0851
13F21F0214
13F21F0524

Unique Device Identifier (UDI)(01)10801902132960 (17)230731 (10)14F21F0253(01)10801902132960 (17)230731 (10)14F21G0239(01)10801902132960 (17)231031 (10)14F21J0114(01)10801902132960 (17)230930 (10)14F21J0372(01)10801902132960 (17)230930 (10)14F21K0052(01)10801902132960 (17)231031 (10)14F21L0138(01)10801902132960 (17)231031 (10)14F21L0139(01)10801902132960 (17)231130 (10)14F21L0215(01)10801902132960 (17)231130 (10)14F21L0216(01)10801902132960 (17)231130 (10)14F21L0220(01)10801902132960 (17)231130 (10)14F21M0014(01)10801902196399 (17)240229 (10)14F22C0105(01)10801902196399 (17)240229 (10)14F22C0106(01)10801902196399 (17)240229 (10)14F22C0107(01)10801902196399 (17)240229 (10)14F22C0108(01)10801902196399 (17)240229 (10)14F22C0109(01)10801902196399 (17)240229 (10)14F22C0110(01)10801902196399 (17)240331 (10)14F22D0085(01)10801902196399 (17)240331 (10)14F22D0086(01)10801902196399 (17)240331 (10)14F22D0087(01)10801902196399 (17)240430 (10)14F22E0114(01)10801902196399 (17)240430 (10)14F22E0117(01)10801902132960 (17)240531 (10)14F22F0008(01)10801902196399 (17)240531 (10)14F22F0090(01)10801902196399 (17)240630 (10)14F22G0124(01)10801902196399 (17)240630 (10)14F22G0125(01)10801902196399 (17)240831 (10)14F22H0345(01)10801902196399 (17)240930 (10)14F22K0030(01)10801902196399 (17)240930 (10)14F22K0159(01)10801902196399 (17)241031 (10)14F22K0222(01)10801902196399 (17)241031 (10)14F22L0072(01)10801902196399 (17)241130 (10)14F22M0039(01)10801902196399 (17)241130 (10)14F22M0040(01)10801902196399 (17)241130 (10)14F22M0117(01)10801902196399 (17)241130 (10)14F22M0118(01)10801902196399 (17)241231 (10)14F23A0178(01)10801902196399 (17)241231 (10)14F23A0310(01)10801902196399 (17)241231 (10)14F23A0311(01)10801902196399 (17)250228 (10)14F23B0326(01)10801902196399 (17)250228 (10)14F23B0327(01)10801902133066 (17)230531 (10)13F21E0851(01)10801902133066 (17)230531 (10)13F21F0214(01)10801902133066 (17)230531 (10)13F21F0524
Page 9 of 10

Appendix 2: Product in scope of EIF-000538

Product Code
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00820-B
EDC-00822
EDC-00822
EDC-00822
EDC-00822
EDC-00822
EDC-00822
EDC-00822-B
EDC-00822-B
EDC-00822-B
EDC-00822-B
EDC-00822-B
EDC-00822-B
EDC-00822-B

Batch
13F21F1021
13F21G1201
13F21H0533
13F21H0824
13F21J0067
13F21J0597
13F21K0048
13F21L0427
13F21M0283
13F22A1064
13F22E0183
13F22G0461
13F22J0599
13F22K1046
13R22J0599
33F23B1066
33F23C0237
33F23C0974
14F21G0118
14F21H0188
14F21L0217
14F22D0102
14F23A0063
14F23B0128
13F21K0049
13F21L0020
13F22E0443
13F22J0463
13F22K0572
13F22L0388
13R22H0448

Unique Device Identifier (UDI)(01)10801902133066 (17)230531 (10)13F21F1021(01)10801902133066 (17)230630 (10)13F21G1201(01)10801902133066 (17)230731 (10)13F21H0533(01)10801902133066 (17)230731 (10)13F21H0824(01)10801902133066 (17)230831 (10)13F21J0067(01)10801902133066 (17)230831 (10)13F21J0597(01)10801902133066 (17)230930 (10)13F21K0048(01)10801902133066 (17)231031 (10)13F21L0427(01)10801902133066 (17)231130 (10)13F21M0283(01)10801902133066 (17)240131 (10)13F22A1064(01)10801902133066 (17)240430 (10)13F22E0183(01)10801902133066 (17)240630 (11)220718 (10)13F22G0461(01)10801902133028 (17)241130 (11)230102 (10)13F22M0459(01)10801902133066 (17)240930 (11)221028 (10)13F22K1046(01)10801902133066 (17)241031 (11)22115 (10)13R22J0599(01)10801902133066 (17)250228 (11)230308 (10)33F23B1066(01)10801902133066 (17)250228 (11)230328 (10)33F23C0237(01)10801902133066 (17)250331 (11)230404 (10)33F23C0974(01)10801902132984 (17)230731 (10)14F21G0118(01)10801902132984 (17)230731 (10)14F21H0188(01)10801902132984 (17)231130 (10)14F21L0217(01)10801902196405 (17)240331 (10)14F22D0102(01)10801902196405 (17)241231 (10)14F23A0063(01)10801902196405 (17)250131 (10)14F23B0128(01)10801902133080 (17)230930 (10)13F21K0049(01)10801902133080 (17)231031 (10)13F21L0020(01)10801902133080 (17)240430 (10)13F22E0443(01)10801902133080 (17)240831 (11)220924 (10)13F22J0463(01)10801902133080 (17)240930 (11)221021 (10)13F22K0572(01)10801902133080 (17)241031 (11)221115 (10)13F22L0388(01)10801902133080 (17)240831 (11)220922 (10)13R22H0448-End of Document-

Page 10 of 10