FDA Device recall Z-1057-2022
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 by Simplivia Healthcare, citing disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1057-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-08 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Simplivia Healthcare |
| Distribution | US |
Product
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Reason
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Identifiers
| code_info | UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE5…UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1057-2022%22
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