Medline Sterile Saline Wound Wash Recalled Due to Potential Sterility Issues
Medline Industries, LP is recalling Medline Sterile Saline Wound Wash because the product may not meet required sterility assurance levels.
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: The product is a sterile wound wash where a failure to meet sterility assurance levels poses a high risk of harm, though no illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP has identified that the manufacturer of Medline Sterile Saline Wound Wash may not have produced products that meet the minimum required sterility assurance level for sterile products.
This recall affects Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), Model Number MDSALINE7. The affected units include all lots.
This product was distributed nationwide in the US and to the Bahamas, Bermuda, and the Cayman Islands.
The recalled product
- Product
- Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 3,578,805
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)
- MDSALINE7 - UDI-DI: 10193489089356 (each)
- 20193489089353 (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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