FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1295-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Status
- Open, Classified
- Initiated
- 2024-01-23
- Posted
- 2024-03-14
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAC
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28