Sterile water FDA Alerts

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

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:

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:

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

Source: FDA

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash Due to Complaints Received on Potential Product Contamination which Compromises Sterility

FDA Publish Date:April 13, 2020 Company Announcement Date:January 28, 2018 -- Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.

The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lot includes the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed Nationwide to wholesale businesses.

Kareway Products, Inc is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.

Consumers with questions regarding this recall can contact the Recall Department at 310-532-0009 or recall@kareway.com available Monday through Fridays from 08:30 am to 05:30 pm (Pacific Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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
• Regular Mail or Fax: Download form 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA