Device 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.
Z-1295-2024
Product summary
- Event
- Event 94036
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37,368 boxes
- Official record key
device-enforcement:Z-1295-2024
Official wording
Reason: Product failed sterility testing.
Code information: Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX. and VA. There was no foreign/government/military distribution.
Derived failure modes
-
Unknown
Product failed sterility testing.