CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 i

FDA device recall Z-1295-2024 · posted 2024-03-14 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Product failed sterility testing.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NAC

Quantity affected

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.

Date initiated

2024-01-23

Date posted

2024-03-14

Location

Northfield, IL