Reported Nov 20, 2013 · Terminated
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for…
DePuy Mitek, Inc., a Johnson & Johnson Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Drive · Raynham, MA · 02767-5199
Is this the product you have?
- DePuy Mitek FMS Intermediary
- Tubing with One-Way valve Product Code281142
- Product UsageThe 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 includingluer 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
- Lot codes and dates
- All lots with a D identifier
- Amount recalled
- 368 pk
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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