FDA Device

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

What You Should Do

Remedy

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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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.
Brand
DePuy Mitek, Inc., a Johnson & Johnson Co.
UPC
Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

Units Affected

15,678

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