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                Recalls, Market Withdrawals, & Safety Alerts

Recalls, Market Withdrawals, & Safety Alerts

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          Recalls, Market Withdrawals, & Safety Alerts
          Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to CanadaRecalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

  
    
        When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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  Company Announcement Date:
             November 06, 2023

                          FDA Publish Date: 
               November 06, 2023
                                    Product Type: 
              Medical Devices
                          Reason for Announcement:
              Recall Reason Description
              Lack of sterility assurance

            Company Name: 
              Nurse Assist, LLC

            Brand Name:
              Brand Name(s)
          Multiple brand names

            Product Description:
              Product Description
          0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP   
Company Announcement



**On November 6, 2023, Nurse Assist, LLC** initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

To date, Nurse Assist, LLC has not received any reports of adverse events for these products.

The product was distributed in the United States and Canada. Recalled Product was distributed from November 1, 2021 to September 18, 2023.

Recalled products include the following products, these products may be packaged inside kits:

Product
			Size0.9% Sodium
			Chloride Irrigation
			USP
			100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 3.1oz
			spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringesSterile Water for
			Irrigation USP
			100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 120 mL
			cups, 10mL syringes, and 30mL syringes

Expiration dates range from November 1, 2023 to September 18, 2025 for all part numbers, with the exception of part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N), which has an expiration date range from November 1, 2023 to September 18, 2028

Detailed product information is as follows:

Brand Name
			Part Number
			Description
			UDINURSE ASSIST
			6492775
			100ML STERILE SALINE BOTTLE
			B15064927754GNURSE ASSIST
			6492776
			100ML STERILE WATER BOTTLE
			B15064927764HNURSE ASSIST
			1010
			10CC PREFILLED SYRINGES
			+B15010104LNURSE ASSIST
			51638
			10CC PREFILLED SYRINGES
			+B150516384%NURSE ASSIST
			1210-BP
			10ML IV FLUSH SYRINGE
			+B1501210BP4GNURSE ASSIST
			6496723
			30CC PREFILLED SYRINGE
			B15064967234DNURSE ASSIST
			52333
			30CC PREFILLED SYRINGES
			+B150523334ZNURSE ASSIST
			1203-BP
			3ML IV FLUSH SYRINGE
			+B1501203BP4INURSE ASSIST
			1205-BP
			5ML IV FLUSH SYRINGE
			+B150120BP4KNURSE ASSIST
			6496722
			SYRINGE PREFILLED 10 ML
			B15064967224CNURSE ASSIST
			1030
			USP STERILE WATER SYRINGE
			+B15010304NNURSE ASSIST
			1030A
			USP STERILE WATER SYRINGE
			+B1501030A4XSTERICARE
			6281
			1000ML STERILE SALINE BOTTLE
			(01)10850421008843STERICARE
			6291
			1000ML STERILE WATER BOTTLE
			(01)10850421008799STERICARE
			6240
			100ML STERILE SALINE BOTTLE
			(01)10850421008812STERICARE
			6250
			100ML STERILE WATER BOTTLE
			(01)10850421008768STERICARE
			6220
			120ML STERILE SALINE FOIL LID CUP
			(01)10850421008874STERICARE
			6210
			120ML STERILE WATER FIOL LID CUP
			(01)10850421008867STERICARE
			6507
			210ML SALINE WOUND FLUSH
			(01)10850421008744STERICARE
			6270
			250ML STERILE SALINE BOTTLE
			(01)10850421008829STERICARE
			6260
			250ML STERILE WATER BOTTLE
			(01)10850421008775STERICARE
			5280
			500ML STERILE SALINE BOTTLE
			850421008907STERICARE
			6280
			500ML STERILE SALINE BOTTLE
			(01)10850421008836STERICARE
			5290
			500ML STERILE WATER BOTTLE
			850421008914STERICARE
			6290
			500ML STERILE WATER BOTTLE
			(01)10850421008782STERICARE
			6503
			90ML USP SALINE WOULD FLUSH
			(01)10850421008751CARDINAL
			1020
			100ML STERILE SALINE BOTTLE
			(01)50192253044490CARDINAL
			1022
			100ML STERILE SALINE BOTTLE
			(01)50192253044506CARDINAL
			PT00103427
			100ML STERILE SALINE BOTTLE
			(01)50192253044506CARDINAL
			1024
			100ML STERILE WATER BOTTLE
			(01)50192253044513CARDINAL
			10000
			100ML STERILE WATER BOTTLE
			(01)50192253044520CARDINAL
			PT00103419
			100ML STERILE WATER BOTTLE
			(01)50192253044513COVIDIEN
			210SAL
			STERILE WOUND SOLUTION
			(01)10884521139756COVIDIEN
			90SAL
			STERILE WOUND SOLUTION
			(01)20884521140940HALYARD OWENS MINOR
			SS003
			0.9% USP SODIUM CHLORIDE INJECTION
			(01)20885632389778HALYARD OWENS MINOR
			SS005
			0.9% USP SODIUM CHLORIDE INJECTION
			(01)20885632389761HALYARD OWENS MINOR
			SS010
			0.9% USP SODIUM CHLORIDE INJECTION
			(01)20885632389754HALYARD OWENS MINOR
			49154
			1000ML STERILE SALINE BOTTLE
			(01)20885632395939HALYARD OWENS MINOR
			49150
			1000ML STERILE WATER BOTTLE
			(01)20885632395892HALYARD OWENS MINOR
			49155
			100ML STERILE SALINE BOTTLE
			(01)20885632395946HALYARD OWENS MINOR
			49151
			100ML STERILE WATER BOTTLE
			(01)20885632395908HALYARD OWENS MINOR
			SS010SFR
			10ML SYRINGE STERILE
			(01)20885632389846HALYARD OWENS MINOR
			49152
			250ML STERILE SALINE BOTTLE
			(01)20885632395915HALYARD OWENS MINOR
			49148
			250ML STERILE WATER BOTTLE
			(01)20885632395878HALYARD OWENS MINOR
			49153
			500ML STERILE SALINE BOTTLE
			(01)20885632395922HALYARD OWENS MINOR
			49149
			500ML STERILE WATER BOTTLE
			(01)20885632395885IDEXX
			98-09444-01
			BOTTLE STERILE WATER 10 PACK
			No UDIMAC MEDICAL
			9210
			10ML FILL SYRINGE LABEL
			20850020865042MCKESSON
			37-6281
			1000ML STERILE SALINE BOTTLE
			612479228399MCKESSON
			37-6291
			1000ML STERILE WATER BOTTLE
			612479228405MCKESSON
			37-6240
			100ML STERILE SALINE BOTTLE
			612479168565MCKESSON
			37-6250
			100ML STERILE WATER BOTTLE
			612479168572MCKESSON
			37-6220
			120ML STERILE SALINE CUP
			612479168558MCKESSON
			37-6210
			120ML STERILE WATER CUP
			612479168541MCKESSON
			37-6507
			210ML SALINE WOUND FLUSH
			612479133761MCKESSON
			37-6270
			250ML STERILE SALINE BOTTLE
			612479168596MCKESSON
			37-6260
			250ML STERILE WATER BOTTLE
			612479168589MCKESSON
			37-6280
			500ML STERILE SALINE BOTTLE
			612479180307MCKESSON
			37-6290
			500ML STERILE WATER BOTTLE
			612479180314MCKESSON
			37-6503
			88.7ML SALINE WOUND FLUSH STERILE
			612479228429MEDICHOICE OWENS MINOR
			SWF071
			CAN STERILE SALINE SPRY MEDI 7.1 OZ
			(01)50885632127043MEDLINE
			DYND1000MLS
			1000ML STERILE SALINE BOTTLE
			(01)208882776699466MEDLINE
			52011
			100ML STERILE SALINE BOTTLE
			Customer KittedMEDLINE
			RDI30296
			100ML STERILE SALINE BOTTLE
			(01)40884389338248MEDLINE
			54380
			100ML STERILE WATER BOTTLE
			Customer KittedMEDLINE
			RDI30295
			100ML STERILE WATER BOTTLE
			(01)40884389338231MEDLINE
			EMZ10091240
			10ML IV FLUSH STERILE FIELD
			(01)20363807109166MEDLINE
			DYND40540
			110ML STERILE SALINE CUP
			(01)40884389334233MEDLINE
			DYND40570
			110ML STERILE WATER CUP
			(01)40884389334226MEDLINE
			PCS1650
			250ML STERILE SALINE BOTTLE
			(01)40884389338262MEDLINE
			PCS1550
			250ML STERILE WATER BOTTLE
			(01)40080196427056MEDLINE
			DYND500MLS
			500ML STERILE SALINE BOTTLE
			(01)40884389118406MEDLINE
			DYND500MLW
			500ML STERILE WATER BOTTLE
			(01)40884389118390MEDLINE
			CURSALINE7
			CAN SALINE STERILE SPRAY CURAD
			40080196297970SOL
			PFF001
			0.9% SODIUM CHLORIDE IV FLUSH SYRINGE
			(01)20810062438895TRUDELL
			T167007
			CUP STERILE SALINE FOIL LID 120 ML
			No UDITRUDELL
			T167005
			CUP STERILE WATER  FOIL LID 120 ML
			No UDIVYAIRE
			4873C
			CUP STERILE SALINE FOIL LID 120 ML
			Discontinued

Recalled products may be repackaged into medical device convenience kits.

The potential for a compromised sterile barrier was identified during routine product testing. Further investigations prompted a widening of product scope out of an abundance of caution.

Consumers who have these products should stop using them and contact their distributor or Nurse Assist, LLC for return authorization.

Nurse Assist, LLC is notifying its distributors and customers by electronic communication and letter and is arranging for replacement of all recalled products. Users are being requested to coordinate the return of product with Nurse Assist, LLC.

Consumers with questions may contact the company via telephone at 800-649-6800 Monday through Friday between the hours of 8am and 430pm (cst). Consumers may also contact the company via e-mail at productremovalinfo@nurseassist.com.

Nurse Assist, LLC has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report **Online:** www.fda.gov/medwatch/report.htm
	**Regular Mail or Fax:** Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178





Company Contact Information
  
  
    Consumers:       

                 Nurse Assist, LLC
        
                 800-649-6800
        
                 productremovalinfo@nurseassist.com

                                                                                  Content current as of:
      11/06/2023
               
             
Regulated Product(s)
		 Medical Devices   
        
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