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.
This recall has been terminated (originally issued August 31, 2017).
- Recall Initiated
- August 31, 2017
- Terminated
- April 9, 2019
- Recall Number
- Z-0695-2018
- Quantity
- 15,678
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Distribution
US Nationwide Distribution
Lot / Code Info
Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
Root Cause
Nonconforming Material/Component
Action Taken
On September 6, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers titled "FMS Gravity Tubing" requesting that customers cease further distribution or use, quarantine all remaining products and contact sales consultant for the coordination of return and replacement. Questions or concerns can be directed to the recall coordinator at 508-828-6609
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