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U.S. Department of Health and Human Services

Class 2 Device Recall CVS Health Waterproof Wound Tracking Dressing

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  Class 2 Device Recall CVS Health Waterproof Wound Tracking Dressing see related information
Date Initiated by Firm January 23, 2024
Date Posted March 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1295-2024
Recall Event ID 94036
Product Classification Dressing, wound, hydrophilic - Product Code NAC
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.
Code Information Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.
Recalling Firm/
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
Manufacturer Reason
for Recall
Product failed sterility testing.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.