OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product — Class II medical device recall Z-1057-2022
Ongoing recall by SIMPLIVIA HEALTHCARE LTD., reported 2022-05-18, distributed nationwide. Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medi
| Recall number | Z-1057-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIMPLIVIA HEALTHCARE LTD., Kiryat Shmona, N/A, Israel |
| Recall initiated | 2022-03-08 |
| Classified | 2022-05-11 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 293,520 |
| UPC / GTIN / UDI-DI | 37290115921435 |
| Lot numbers | UBE507, UBE508, UBE509, UBE511, UBE512, UBE513, UBE514, UBE515, UBE516, UBE517, UBE518, UBE526, UBE530, UBE531, UBE533, UBE534, UBE535, UBE536 |
Product
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Reason for recall
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
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-1057-2022. 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.