Medical device recalls Moderate risk

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from ir…

Recall date
August 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0695-2018
FDA classification
Class II
Brand / firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Sold / distributed
US Nationwide Distribution

Why it was recalled

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

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

What was recalled

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

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