RecallRadar

FDA Device recall Z-1057-2022

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

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

AgencyFDA Device
Recall numberZ-1057-2022
ClassificationClass II
Statusongoing
Initiated2022-03-08
Published2022-05-18
Last updated2026-09-13 11:56 UTC
CompanySimplivia Healthcare
DistributionUS

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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.