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.

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-0695-2018

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