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U.S. Department of Health and Human Services

Class 2 Device Recall FMS Gravity Tube Set

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  Class 2 Device Recall FMS Gravity Tube Set see related information
Date Initiated by Firm August 31, 2017
Create Date February 23, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-0695-2018
Recall Event ID 79117
Product Classification Catheter, infusion - Product Code JCY
Product 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.
Code Information Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information Contact Jennifer Lawrence
508-880-8100
Manufacturer Reason
for Recall		 Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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
Quantity in Commerce 15,678
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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