The Recall Desk

FDA (Devices) recall action 66145

DePuy Mitek, Inc., a Johnson & Johnson Co. recalled 2 products on 2013-11-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-20
Critical
0
Units
29,648

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2013-11-20

    DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.

    Product
    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 int
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-11-20

    DePuy Mitek FMS Outflow Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Outflow Tubing because the pillow valve may not perform as intended, potentially leading to backflow of irrigation fluid and patient cross-contamination.

    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
    Category
    Distribution
    0 states