SIMPLIVIA HEALTHCARE LTD. recalls OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Recall date

March 8, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1057-2022

FDA classification

Class II

Brand / firm

SIMPLIVIA HEALTHCARE LTD.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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