FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
- Recall number
- Z-0902-2022
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
- Status
- Completed
- Initiated
- 2022-03-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product was distributed without being sterilized.
- Root cause
- Under Investigation by firm
- Action
- A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information.
- Quantity
- 486,578 pairs
- Distribution
- Product distributed throughout United States and Guam
- Lot, serial or model codes
- Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939
- 510(k) numbers
- ["K110272"]
- PMA numbers
- not on file
- Product code
- KGO
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28