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
USP100 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 USP100 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 [email protected].
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