Meijer Saline Wound Wash Recall - Sterility Issue
Summary
The FDA has initiated a Class II recall for Meijer STERILE saline wound wash due to a potential sterility issue. The manufacturer may not have met the minimum required sterility assurance level for sterile products. Distribution was nationwide in the US and to the Bahamas, Bermuda, and Cayman Islands.
What changed
Medline Industries, LP is recalling Meijer STERILE saline wound wash (Model Number MJSALINE7) due to a potential failure to meet minimum sterility assurance levels. This recall is classified as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of adverse health consequences is remote. The product was distributed nationwide in the US and internationally to the Bahamas, Bermuda, and Cayman Islands.
Companies that may have received this product should immediately review their inventory and quarantine any affected units. While the recall is ongoing, affected parties should follow Medline's instructions for product return or disposition. The FDA's classification suggests a low probability of adverse health consequences, but proper handling and removal of the product from circulation are critical to prevent any potential risks.
What to do next
- Review inventory for affected Meijer STERILE saline wound wash.
- Quarantine any identified affected units.
- Follow Medline's instructions for product return or disposition.
Source document (simplified)
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1435-2026 · 20260304 · Ongoing
Product
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Reason for Recall
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Distribution
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Source: openFDA Enforcement API
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