Z-1835-2024Class II

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

Name: Z-1835-2024 CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile...
Creator: Cardinal Health 200, LLC
Published: 2024-04-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-04-17 / Open, Classified

FDA source

Cardinal Health 200, LLC began a recall of CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic on 2024-04-17. FDA classified it as Class II and gives the reason as "Potential contamination of the product with latex adhesive residual". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1835-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-16
Recalling firm: Medtronic, Inc.
Product: CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: Potential contamination of the product with latex adhesive residual.
FDA root cause: 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.
Product codes and lots: Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1835-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-16

Product code KGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)