HCT 500mL BAGS — Class II medical device recall Z-0936-2023
Ongoing recall by Stradis Healthcare, reported 2023-01-18, distributed nationwide. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility
| Recall number | Z-0936-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, Waukegan, IL, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-11 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 644 units |
| Reason classes | sterility, packaging |
| Lot numbers | 220602531 |
Product
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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-0936-2023. 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.