Recall Z-0192-2014— DePuy Mitek, Inc., a Johnson & Johnson Co.

Name: FDA recall Z-0192-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Class II · Terminated

Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2013-08-29, terminated 2016-05-12. It names 2 FDA 510(k) clearances: K002040, K954465. Product: DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.. Reason: Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination.

Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Terminated: 2016-05-12
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K002040 — FMS SOLOFuture Medical Systems, Inc.·cleared 2000-09-11
K954465 — FMS DUOFuture Medical Systems, Inc.·cleared 1995-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.

Reason for recall

Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

Data sourced from openFDA. This site is unofficial and independent of the FDA.