CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek FMS Intermediary Tubing with One-Way valve, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0191-2014
- FDA event ID
- 66145
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2013
- FDA classified
- 8 Nov 2013
- Reported
- 20 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 29 Aug 2013 | Recall initiated by company | |
| 8 Nov 2013 | Classified by FDA | +71 days |
| 20 Nov 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 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 Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
All lots with a D identifier
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66145| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DePuy Mitek FMS Outflow Tubing with One-Way valve Product recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
More recalls from DePuy Mitek, Inc., a Johnson & Johnson
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | COR Disposable Kit w/ Perpendicularity recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | COR Disposable Kit Cartilage Transplant System recalled | DePuy Mitek, Inc., a Johnson & Johnson | Other | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
| Device | CLASS II | DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled | DePuy Mitek, Inc., a Johnson & Johnson | Device Malfunction | Nationwide |
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