Sodium chloride 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

0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter

[Posted 02/18/2016]

ISSUE: Baxter International is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution - Lot G120162, expiration 11/30/2018 - to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect.

Sodium Chloride Irrigation solution with foreign material contamination potentially could result in a series of complications dependent in which anatomic location the irrigation is used, which could include inflammatory reaction, foreign body reaction, and infection which could be life-threatening.

BACKGROUND: 0.9% Sodium Chloride for Irrigation USP – 500 mL is an isotonic solution intended for irrigation. This solution can be used to rinse debris and residue from wounds and as a single use for rinsing/irrigation during surgical procedures. It may also be used to flush or rinse medical equipment such as catheters.

The lot being recalled was distributed to customers and distributors in the United States between November 12, 2015 and January 11, 2016.

RECOMMENDATION: Baxter is notifying its distributors and customers by letter that they should not use product from the recalled lot. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[02/17/2016 - Press Release - Baxter]