April 26, 2024
The Food and Drug Administration (FDA) is advising establishments that manufacture human cells, tissues and cellular and tissue-based products (HCT/Ps) about a recall of products that may have been used in manufacturing HCT/Ps. FDA is posting this information in response to questions from manufacturers about the recall.
Summary of the Issue
On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile and may potentially be contaminated with bacteria which could cause serious or life-threatening infections:
- 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3 mL syringes, 5 mL syringes, and 10mL syringes);
- Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10 mL syringes, and 30 mL syringes).
These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit.
Refer to the Nurse Assist, LLC recall announcement for the list of products.
Considerations for Manufacturers of HCT/Ps
- Check your supply of saline (0.9% sodium chloride) and sterile water medical products to determine whether you have any of the recalled products in your inventory.
- Do not use these recalled products and follow the recommendations in the company’s recall announcement.
- Be aware that these recalled products may be available as individual units or may be included as part of a kit.
- If you have questions about this recall, contact Nurse Assist, LLC by phone at 800-649-6800 Monday through Friday between the hours of 8:00 am and 4:30 pm (CST) or by e-mail at productremovalinfo@nurseassist.com.
Risk Mitigation Strategies
HCT/P establishments must recover, process, store, label, package, and distribute HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable disease (21 CFR 1271.145). Establishments must not make available for distribution an HCT/P that is contaminated or that otherwise does not meet release criteria designed to prevent communicable disease transmission (21 CFR 1271.265(c)(2)).
Establishments that have used the recalled products described above to manufacture their HCT/Ps should consider performing a risk assessment to evaluate and identify the potential for introduction, transmission, or spread of communicable disease. The risk assessment considerations include, but are not limited to, the type of HCT/P, processing and processing controls, and any mitigating step(s) to minimize the potential for contamination of the final product.
Reporting to FDA
If you determine that a distributed HCT/P manufactured using the recalled products is contaminated, an HCT/P deviation report is required under 21 CFR 1271.350(b) [FDA Industry Systems]. Questions concerning HCT/P deviation reporting may be sent to HCTP_deviations@fda.hhs.gov.
If you receive information of an adverse reaction associated with use of an HCT/P manufactured using the recalled products, an HCT/P adverse reaction report may be required under 21 CFR 1271.350(a) [Form FDA 3500A - Mandatory Reporting]. Questions concerning reporting HCT/P adverse reactions may be sent to HCTPAdverseReactionReporting@fda.hhs.gov.
Report any adverse events related to the use of other FDA-regulated products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.
Questions?
If you have questions, you may contact FDA’s Center for Biologics Evaluation and Research (CBER) at industry.biologics@fda.hhs.gov.
