FDA-Device2022-05-18Class II

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

SIMPLIVIA HEALTHCARE LTD.
Hazard

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

Sold states
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.
Affected count
293,520
Manufactured in
NORTH IND. ZONE, (MIGADA PLANT), NORTH IND. ZONE PoBOX 888, Kiryat Shmona, N/A, Israel
Products
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Official notice

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

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