FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1295-2024
·
Reported March 20, 2024
Enforcement
- Recall Number
- Z-1295-2024
- Event ID
- 94036
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 20, 2024
- Initiation Date
- January 23, 2024
- Classification Date
- March 14, 2024
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
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.
Reason
Product failed sterility testing.
Code Info
Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
Distribution
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.
Quantity
37,368 boxes