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Curity recallZ-1835-2024 · Cardinal Health 200, LLC · initiated Apr 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential contamination of the product with latex adhesive residual.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1835-2024
Status
Open, Classified
Initiated by the company
Apr 17, 2024
Posted by the FDA
May 16, 2024
Recalling firm
Cardinal Health 200, LLC
Quantity
2,000 packages
Product code
KGX
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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