FDA recall Z-1057-2022

SIMPLIVIA HEALTHCARE LTD. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2022-03-08
Report date
2022-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kiryat Shmona, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2022