Z-1295-2024 Class II Ongoing
FDA device recall Z-1295-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jan 23, 2024 and is designated Class II. Reason for recall: Product failed sterility testing. The recall status is ongoing. Affected quantity: 37,368 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Jan 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,368 boxes
Product 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 for Recall
Product failed sterility testing.
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.
Code Information
Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1295-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026