OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Check against the official notice below — it lists the full affected range.
Simplivia Healthcare Ltd. is recalling the OnGuard2 Bag Adaptor SP, a chemotherapy closed-system transfer device (CSTD) product, due to a hazard where the adaptor may disconnect from infusion bags, potentially causing hazardous medications to spill. The product was distributed nationwide across all 50 states, with approximately 293,520 units affected across multiple lot numbers (UBE507 through UBE536).
The recall notice does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Reason for recall: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications. 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 Lot/code info: UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.