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U.S. Department of Health and Human Services

Class 2 Device Recall CardinalHealth Curity Flexible Adhesive Bandage XLarge

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  Class 2 Device Recall CardinalHealth Curity Flexible Adhesive Bandage XLarge see related information
Date Initiated by Firm April 17, 2024
Date Posted May 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1835-2024
Recall Event ID 94407
Product Classification Tape and bandage, adhesive - Product Code KGX
Product CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Code Information Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
847-887-5500
Manufacturer Reason
for Recall		 Potential contamination of the product with latex adhesive residual.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 4/17/2024, the recalling firm issued letters dated 4/17/2024 via overnight mail explaining the reason for recall, the risk to health, and the required actions, which were: (1) Review inventory for the affected product code and lot number; (2) communicate with all personnel that utilize the product; (3) segregate and quarantine all affected product and utilize the return directions in the letter; (4) disseminate the notice to all departments, clinics, and external campuses that handle the affected product; (5) distributors are to notify any customers to whom they may have distributed/forwarded the affected product to or plan to send the product; (6) return the enclosed acknowledgment form via FAX or email whether or not the consignee has the product. The letter contained the various phone numbers for the Customer Service groups (hospital, federal government, distributor, and all other customers) to arrange for return of the product and for questions related to the recall. An attachment was enclosed with the letter to show an example of where the lot number can be located on the label.
Quantity in Commerce 2,000 packages
Distribution US Nationwide 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.
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