Sterile saline wound wash may not meet required sterility assurance level
Medline is recalling Meijer Sterile Saline Wound Wash First Aid Cleansing Spray because the manufacturer may not have made the product to the minimum sterility assurance level required for sterile products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a product applied to open wounds that may not be sterile, with no injuries stated in the source.
Plain-English summary
Medline Industries, LP is recalling Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP sodium chloride, 7.1 fl oz (210 mL), model number MJSALINE7. About 104,608 units were distributed worldwide, covering the United States nationwide and the Bahamas, Bermuda and the Cayman Islands. The FDA has classified this recall as Class II.
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.
All lots are affected. The product carries UDI-DI 00708820657052 for the unit and 10708820657059 for the case.
Consumers and facilities can identify affected product by the model number and UDI codes above, and may contact Medline Industries, LP for further information.
The recalled product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Wound care
- Affected units
- 104,608
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number MJSALINE7 - UDI-DI: 00708820657052 (unit)
- 10708820657059 (case)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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