Z-0902-2022Class II

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Name: Z-0902-2022 Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Creator: Cardinal Health 200, LLC
Published: 2022-03-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-03-15 / Completed / root cause: sterility

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves on 2022-03-15. FDA classified it as Class II and gives the reason as "Product was distributed without being sterilized". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0902-2022
Classification: Class II
Status: Completed
Initiated: 2022-03-15
Posted: 2022-04-09
Recalling firm: Medtronic, Inc.
Product: Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Product code: KGO Surgeon'S Gloves
Reason for recall: Product was distributed without being sterilized.
Root cause tag: sterility
FDA 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 in commerce: 486,578 pairs
Distribution: Product distributed throughout United States and Guam
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0902-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0902-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-20	2022-04-08

Product code KGO

K110272Class ISterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy DrugCardinal Health, Inc. / cleared 2011-06-08

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)