Protexis Neoprene Surgical Glove — Class II medical device recall Z-0635-2019
Terminated recall by Cardinal Health 200, LLC, reported 2018-12-26, distributed nationwide. Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Th
| Recall number | Z-0635-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2018-10-31 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2025-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CL, CR, DE, ES, FR, GB, IT, LU, NL, PL, SE, TW |
| Quantity | 1,475,095 pairs |
| Reason classes | labeling |
| Lot numbers | TS18060009, TS18060145, TS18060251, TS18060322, TS18070037, TS18070122, TS18070312, TS18070380, TS18080033, TS18080350, TS18090125, TS18090154, TS18090213, TS18090290 |
Product
Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Reason for recall
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
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-0635-2019. 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.