Smiths Medical ASD Inc. recalls medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-1…

Recall date

May 10, 2018

Source

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

Recall number

Z-0155-2022

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.

Why it was recalled

Product has a lack of sterility assurance

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

What was recalled

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE