Recall Z-1295-2024 ยท NAC Dressing, Wound, Hydrophilic
MEDLINE INDUSTRIES, LP - Northfield
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.
| Date | Mar 14, 2024 (initiated Jan 23, 2024) |
| Status | Open, Classified |
| Reason | Product failed sterility testing. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm originally initiated the recall by letter dated and issued on 1/23/2024 via email regarding lot #10322040003. The letter explained the issue, risk, and that no reports of illness or injury have been received due to this issue. The required actions listed in the letter were: (1) Immediately check your stock for the affected item and lot numbers listed on the attachment and quarantine all affected product; (2) Return the enclosed response form. Once the response form is received, the consignee will be sent return labels and the account will receive credit when the returne |
| Quantity | 37,368 boxes |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.