Procedure pack: Presource PBDS — Class II medical device recall Z-0085-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2023-10-18, distributed nationwide. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
| Recall number | Z-0085-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-08-16 |
| Classified | 2023-10-10 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,351 packages |
| UPC / GTIN / UDI-DI | 10195594543259 |
| Lot numbers | 967679 |
| Expiration dates | 2024-09-01 |
Product
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Reason for recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
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-0085-2024. 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.