SIMPLIVIA HEALTHCARE LTD. Recall 89952
Description: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
SIMPLIVIA HEALTHCARE LTD. Recall 89952 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1057-2022 |
| Event ID | 89952 |
| Event Description | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 |
| Product Type | Devices |
| Distribution | Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY. |
| Quantity | 293,520 |
| Recall Reason | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. |
| Device Classification | 20220518 |
| Device Code Info | UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536 |
| Center Classification Date | 20220511 |
| Recall Initiation Date | 20220308 |
| Recalling Firm | SIMPLIVIA HEALTHCARE LTD. |
| Initial Notification | |
| Similar To |