—#206176

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.

FDA product code: NAC — Dressing, Wound, Hydrophilic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.

Why it was recalled

Product failed sterility testing.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 returned product is received; (3) If the product has been transferred to another individual, department, or location, the consignee is to notify their customer and have them return the affected product to the consignee for subsequent return to the recalling firm. A list of impacted CVS locations was included in the letter. When the additional sterility results were received, the recall was expanded to include the other lots by letter dated and issued on 2/1/2024 via email. The letter explained that additional lot numbers are now impacted and the remainder of the letter contained the same information as the initial letter on 1/23/2024.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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.

Timeline

Recall initiated: 2024-01-23
Posted by FDA: 2024-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206176. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.