Recall Z-0695-2018 ยท JCY Catheter, Infusion
DePuy Mitek, Inc., a Johnson & Johnson Co.
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.
| Date | Aug 31, 2017 |
| Status | Terminated |
| Reason | Leakage of FMS gravity tub sets (281113) at the bulb and tube connection |
| Root cause | 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 | 15,678 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.