CVS Health Wound Dressing Recalled for Failed Sterility Testing
Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.
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: FDA Class II medical device recall for sterility failure. The non-sterile dressings present a risk of harm through potential infection, but no illnesses or injuries have been reported.
Plain-English summary
CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) is being recalled due to product sterility failure. The immediate package contains one sterile dressing measuring 4 inches by 4 inches, with 4 dressings per box and 24 boxes per case.
The manufacturer, Medline Industries LP of Northfield, identified that the product failed sterility testing. Non-sterile wound dressings could introduce contamination and pose an infection risk when applied to wounds.
The recall affects 37,368 boxes distributed nationwide in Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia. The affected lot numbers are 10322040003, 10322050003, 10322070006, and 10322100002, with UDI-DI 0500428645208.
Consumers who have purchased this product should not use it. If you have already used an affected dressing, consult your healthcare provider.
The recalled product
- Product
- CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Wound Dressing
- Affected units
- 37,368
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 (5)
- Lot numbers 10322040003
- 10322050003
- 10322070006
- and 10322100002
- UDI-DI 0500428645208.
Distribution
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