FDA-Device2018-03-07Class II
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.
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Sold states
US Nationwide Distribution
Affected count
15,678
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2018Don't want to check this manually?
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