Z-0695-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- August 31, 2017
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,678
Product Description
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.
Reason for Recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Distribution Pattern
US Nationwide Distribution
Code Information
Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645