Recall archive / FDA device enforcement
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves — FDA record Z-0902-2022
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
- Reason
- Product was distributed without being sterilized.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 486,578 pairs
- Agency-reported status
- Completed
- Source record identifier
- Z-0902-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product distributed throughout United States and Guam
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Mar 15, 2022
- Center classification date
- Apr 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.