FDA recall Z-0695-2018

DePuy Mitek, Inc., a Johnson & Johnson Co. · Class II · device

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 for recall

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

Distribution

US Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2017-08-31
Report date: 2018-03-07
Termination date: 2019-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2018