—#207175

Product

CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.

FDA product code: KGX — Tape And Bandage, Adhesive
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)

Why it was recalled

Potential contamination of the product with latex adhesive residual.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-04-17
Posted by FDA: 2024-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.