Recall Z-0695-2018— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2017-08-31, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-31
- Terminated
- 2019-04-09
- Firm location
- Raynham, MA, United States
Product description
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.
Reason for recall
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Data sourced from openFDA. This site is unofficial and independent of the FDA.