Device product
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Z-1057-2022
Product summary
- Event
- Event 89952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 293,520
- Official record key
device-enforcement:Z-1057-2022
Official wording
Reason: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Code information: UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
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.
Derived failure modes
-
Unknown
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.