Z-1057-2022 Class II Ongoing

Recalled by SIMPLIVIA HEALTHCARE LTD. — Kiryat Shmona, N/A

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