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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