CAREFUSION recalls MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be use…

Recall date

June 9, 2021

Source

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

Recall number

Z-1995-2021

FDA classification

Class II

Brand / firm

CAREFUSION

Sold / distributed

U.S.: TN O.U.S.: None

Why it was recalled

A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.

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

What was recalled

MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.