Z-1295-2024Class II

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

Name: Z-1295-2024 CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-01-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-01-23 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on 2024-01-23. FDA classified it as Class II and gives the reason as "Product failed sterility testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1295-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-23
Posted: 2024-03-14
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.
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: Product failed sterility testing.
Root cause tag: sterility
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code NAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)