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

FDA device recall Z-1835-2024 · posted 2024-05-16 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

Potential contamination of the product with latex adhesive residual.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KGX

Quantity affected

2,000 packages

Distribution

US Nationwide distribution.

Date initiated

2024-04-17

Date posted

2024-05-16

Location

Waukegan, IL