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 AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
-
Recall Reason DescriptionLack of sterility assurance
- Company Name:
- Nurse Assist, LLC
- Brand Name:
-
Brand Name(s)Multiple brand names
- Product Description:
-
Product Description0.9% 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.
- 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