Cardinal Health PROTEXIS PI and PI Classic — Class II medical device recall Z-0902-2022
Completed recall by Cardinal Health 200, LLC, reported 2022-04-20, distributed in GU. Product was distributed without being sterilized.
| Recall number | Z-0902-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2022-03-15 |
| Classified | 2022-04-08 |
| Reported by FDA | 2022-04-20 |
| Distributed | GU |
| Quantity | 486,578 pairs |
| UPC / GTIN / UDI-DI | 10885380031762, 10885380031939, 20885380031769, 20885380031936, 50885380031760, 50885380031937 |
| Lot numbers | TS21050195, TS21050215 |
| Expiration dates | 2024-04-30 |
Product
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Reason for recall
Product was distributed without being sterilized.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0902-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.