Z-1057-2022 Class II Ongoing
FDA device recall Z-1057-2022 was initiated by SIMPLIVIA HEALTHCARE LTD. on March 8, 2022 and is designated Class II. Reason for recall: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. The recall status is ongoing. Affected quantity: 293,520.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293,520
Product Description
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.
Distribution Pattern
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.
Code Information
UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536