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Recall Observatory FDA recall evidence

Device product

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Z-1057-2022

March 08, 2022

Class II

Product summary

Firm
SIMPLIVIA HEALTHCARE LTD.
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

    reason.no_named_rule · v1.0.0

    Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.