Amended - 11/22/2016
Urgent Medical Device Recall Notification
LMA® MAD Nasal™ Intranasal Mucosal Atomization Device
November 22, 2016
To: Customer of Teleflex Medical Products
Teleflex Medical Incorporated (“Teleflex Medical”) has issued a recall for the product codes and lot numbers listed on
Attachment A. Teleflex is recalling these products as they may not deliver a fully atomized plume of medication.
Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomizedspray. Because the device is inserted into the nose to deliver medication, it may not be possible during actual use todetermine whether it is delivering a plume or a stream.
The failure of the device to deliver an atomized plume may impair the effectiveness of the medication with which it isused. This is most critical in certain emergency situations, such as where the device is used in an off-label manner fordelivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycemia, ortreatment of epileptic seizures.
Please continue to return affected product for a full refund per the procedures set forth in our letter of October 27, 2016.
Some customers have indicated that, due to medical necessity, they plan to continue using the affected lots rather thanreturn them. By this letter, Teleflex is advising all such customers to follow the supplemental Instructions for Use
included as Attachment B. These supplemental instructions allow non-destructive testing of each unit prior to theprocedure to determine if it is defective. Please ensure there are replacement devices available.
Please ensure these instructions are distributed to all users as required.
If your institution intends to continue using affected lots with this supplemental testing, please send theacknowledgement form to recalls@teleflex.com with your name and contact information and the lots that you willcontinue to use, or call 866-246-6990, so that we may track who is following this procedure. You may choose to follow
either or both pathways – for example, returning lots 1 and 2, while notifying us that you are retaining lot 3 and applying
the supplemental instructions enclosed with this letter.
The U.S. Food and Drug Administration has been notified of this supplement to our original recall letter.
Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any
inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local
sales representative or Customer Service at 1-866-246-6990.
For and on behalf of Teleflex Medical,

Karen Boylan
Karen Boylan
VP, Global RA/QA
Enclosures{00266907}

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Immediate Attention Requested
Amended Recall Acknowledgment Form for:LMA® MAD Nasal™ Intranasal Mucosal Atomization DeviceCheck the appropriate box and fax this form to 1-855-419-8507 or email to recalls@teleflex.com.

We have no inventory within the scope of this recall.
We have the following affected product at our facility and have discontinued use and distribution. We havequarantined the affected product, and will return the following quantities.

Product Code

Batch/Lot#

Quantity

Product Code

Batch/Lot#

QuantityYour account will be credited when the returned product is received.

We have the following affected product at our facility and will continue to use and follow the supplementalinstructions for non-destructive pre-testing.

Product Code

Batch/Lot#Quantity

Product CodeBatch/Lot#

We have distributed the supplemental instructions for use to all users as required.

Page 1 of 2Quantity

Please print legibly.

(Print Name)(Date)(Signature)(Telephone Number)(Institution Name)(Email Address)(Institution Street Address)

Alternate Mailing Address(Institution City, State, Zip)

(Street Address)(Country)(City, State, Zip)

Teleflex Medical Use Only

Received By:

Date:Page 2 of 2

Attachment ALMA® MAD Nasal™ Intranasal Mucosal Atomization Device
Products and Lots/Batches
Product Code

MAD100MAD100OS

MAD110
MAD110OS

MAD130Batch/ Lot#
160105160137160302160321160402160435160506160523160609160620160707160802160813160322160524160630160217160507160240160312160107160138160517

Product Code
MAD130OS

MAD140MAD140OS

MAD300Batch/ Lot#
160436160803160125160218160437160610160801160226160438160727160108160117160126160145160146160200160219160225160231160300160313160327160400

Product CodeMAD300MAD300B

Batch/ Lot#
160409160422160432160440160500160518160602160611160621160631160701
160708160718160728160800160804160814160816160823160410Attachment BLMA® MAD Nasal™ Intranasal Mucosal Atomization Device
Supplemental Instructions for Continued Use of Recalled Lots

To continue the use of products affected by this recall please follow the below pre‐test procedure.
Note: This pre‐test is not required for lots not affected by this recall.

Ensuring Appropriate Device Output:

Prior to use, please test the device as follows:Attach a syringe containing 1ml of either sterile water or sterile saline to the device.

Briskly compress the plunger on the syringe so as to deliver the liquid through the device
and observe how the liquid comes out at the [distal] end.

If the liquid sprays in a fine mist then the device is atomizing as intended

If testing the device demonstrates streaming, select another MAD device for testing anduse.

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