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 |
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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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