Z-0192-2014Class II

DePuy Mitek FMS Outflow Tubing with One-Way valve

Name: Z-0192-2014 DePuy Mitek FMS Outflow Tubing with One-Way valve
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2013-08-29
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2013-08-29 / Terminated

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS Fluid Management Systems connects the... on 2013-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0192-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2013-11-08
Terminated: 2016-05-12
Recalling firm: DePuy Mitek, Inc.
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.
Product code: HRX Arthroscope
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
FDA root cause: Component change control
Action: DePuy Mitek inititaed telephone notification on Ausgust 29, 2013 and sent an Urgent Voluntary Product Recall letter dated September 5, 2013 to US and OUS affected customers/affiliates. The customers were notified of the affected products, problem and actions to be taken. The customers were instructed to immediately check all inventories to locate and return affected product following the enclosed instructions. Stericycle is cooridianting the returns. If you have any questions or concerns in regards to this recall, please contact Stericycle directly at 1-866-737-1928.
Quantity in commerce: 29280 units
Distribution: Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0192-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0191-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08
Z-0192-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

Product code HRX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)