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  4. Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
  1. Recalls, 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.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
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 Size
0.9% 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 syringes
Sterile 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 UDI
NURSE ASSIST 6492775 100ML STERILE SALINE BOTTLE B15064927754G
NURSE ASSIST 6492776 100ML STERILE WATER BOTTLE B15064927764H
NURSE ASSIST 1010 10CC PREFILLED SYRINGES +B15010104L
NURSE ASSIST 51638 10CC PREFILLED SYRINGES +B150516384%
NURSE ASSIST 1210-BP 10ML IV FLUSH SYRINGE +B1501210BP4G
NURSE ASSIST 6496723 30CC PREFILLED SYRINGE B15064967234D
NURSE ASSIST 52333 30CC PREFILLED SYRINGES +B150523334Z
NURSE ASSIST 1203-BP 3ML IV FLUSH SYRINGE +B1501203BP4I
NURSE ASSIST 1205-BP 5ML IV FLUSH SYRINGE +B150120BP4K
NURSE ASSIST 6496722 SYRINGE PREFILLED 10 ML B15064967224C
NURSE ASSIST 1030 USP STERILE WATER SYRINGE +B15010304N
NURSE ASSIST 1030A USP STERILE WATER SYRINGE +B1501030A4X
STERICARE 6281 1000ML STERILE SALINE BOTTLE (01)10850421008843
STERICARE 6291 1000ML STERILE WATER BOTTLE (01)10850421008799
STERICARE 6240 100ML STERILE SALINE BOTTLE (01)10850421008812
STERICARE 6250 100ML STERILE WATER BOTTLE (01)10850421008768
STERICARE 6220 120ML STERILE SALINE FOIL LID CUP (01)10850421008874
STERICARE 6210 120ML STERILE WATER FIOL LID CUP (01)10850421008867
STERICARE 6507 210ML SALINE WOUND FLUSH (01)10850421008744
STERICARE 6270 250ML STERILE SALINE BOTTLE (01)10850421008829
STERICARE 6260 250ML STERILE WATER BOTTLE (01)10850421008775
STERICARE 5280 500ML STERILE SALINE BOTTLE 850421008907
STERICARE 6280 500ML STERILE SALINE BOTTLE (01)10850421008836
STERICARE 5290 500ML STERILE WATER BOTTLE 850421008914
STERICARE 6290 500ML STERILE WATER BOTTLE (01)10850421008782
STERICARE 6503 90ML USP SALINE WOULD FLUSH (01)10850421008751
CARDINAL 1020 100ML STERILE SALINE BOTTLE (01)50192253044490
CARDINAL 1022 100ML STERILE SALINE BOTTLE (01)50192253044506
CARDINAL PT00103427 100ML STERILE SALINE BOTTLE (01)50192253044506
CARDINAL 1024 100ML STERILE WATER BOTTLE (01)50192253044513
CARDINAL 10000 100ML STERILE WATER BOTTLE (01)50192253044520
CARDINAL PT00103419 100ML STERILE WATER BOTTLE (01)50192253044513
COVIDIEN 210SAL STERILE WOUND SOLUTION (01)10884521139756
COVIDIEN 90SAL STERILE WOUND SOLUTION (01)20884521140940
HALYARD OWENS MINOR SS003 0.9% USP SODIUM CHLORIDE INJECTION (01)20885632389778
HALYARD OWENS MINOR SS005 0.9% USP SODIUM CHLORIDE INJECTION (01)20885632389761
HALYARD OWENS MINOR SS010 0.9% USP SODIUM CHLORIDE INJECTION (01)20885632389754
HALYARD OWENS MINOR 49154 1000ML STERILE SALINE BOTTLE (01)20885632395939
HALYARD OWENS MINOR 49150 1000ML STERILE WATER BOTTLE (01)20885632395892
HALYARD OWENS MINOR 49155 100ML STERILE SALINE BOTTLE (01)20885632395946
HALYARD OWENS MINOR 49151 100ML STERILE WATER BOTTLE (01)20885632395908
HALYARD OWENS MINOR SS010SFR 10ML SYRINGE STERILE (01)20885632389846
HALYARD OWENS MINOR 49152 250ML STERILE SALINE BOTTLE (01)20885632395915
HALYARD OWENS MINOR 49148 250ML STERILE WATER BOTTLE (01)20885632395878
HALYARD OWENS MINOR 49153 500ML STERILE SALINE BOTTLE (01)20885632395922
HALYARD OWENS MINOR 49149 500ML STERILE WATER BOTTLE (01)20885632395885
IDEXX 98-09444-01 BOTTLE STERILE WATER 10 PACK No UDI
MAC MEDICAL 9210 10ML FILL SYRINGE LABEL 20850020865042
MCKESSON 37-6281 1000ML STERILE SALINE BOTTLE 612479228399
MCKESSON 37-6291 1000ML STERILE WATER BOTTLE 612479228405
MCKESSON 37-6240 100ML STERILE SALINE BOTTLE 612479168565
MCKESSON 37-6250 100ML STERILE WATER BOTTLE 612479168572
MCKESSON 37-6220 120ML STERILE SALINE CUP 612479168558
MCKESSON 37-6210 120ML STERILE WATER CUP 612479168541
MCKESSON 37-6507 210ML SALINE WOUND FLUSH 612479133761
MCKESSON 37-6270 250ML STERILE SALINE BOTTLE 612479168596
MCKESSON 37-6260 250ML STERILE WATER BOTTLE 612479168589
MCKESSON 37-6280 500ML STERILE SALINE BOTTLE 612479180307
MCKESSON 37-6290 500ML STERILE WATER BOTTLE 612479180314
MCKESSON 37-6503 88.7ML SALINE WOUND FLUSH STERILE 612479228429
MEDICHOICE OWENS MINOR SWF071 CAN STERILE SALINE SPRY MEDI 7.1 OZ (01)50885632127043
MEDLINE DYND1000MLS 1000ML STERILE SALINE BOTTLE (01)208882776699466
MEDLINE 52011 100ML STERILE SALINE BOTTLE Customer Kitted
MEDLINE RDI30296 100ML STERILE SALINE BOTTLE (01)40884389338248
MEDLINE 54380 100ML STERILE WATER BOTTLE Customer Kitted
MEDLINE RDI30295 100ML STERILE WATER BOTTLE (01)40884389338231
MEDLINE EMZ10091240 10ML IV FLUSH STERILE FIELD (01)20363807109166
MEDLINE DYND40540 110ML STERILE SALINE CUP (01)40884389334233
MEDLINE DYND40570 110ML STERILE WATER CUP (01)40884389334226
MEDLINE PCS1650 250ML STERILE SALINE BOTTLE (01)40884389338262
MEDLINE PCS1550 250ML STERILE WATER BOTTLE (01)40080196427056
MEDLINE DYND500MLS 500ML STERILE SALINE BOTTLE (01)40884389118406
MEDLINE DYND500MLW 500ML STERILE WATER BOTTLE (01)40884389118390
MEDLINE CURSALINE7 CAN SALINE STERILE SPRAY CURAD 40080196297970
SOL PFF001 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE (01)20810062438895
TRUDELL T167007 CUP STERILE SALINE FOIL LID 120 ML No UDI
TRUDELL T167005 CUP STERILE WATER  FOIL LID 120 ML No UDI
VYAIRE 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.

 


Company Contact Information

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