The Recall Desk

FDA (Devices) recall action 82039

ConvaTec, Inc recalled 4 products on 2019-03-27

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-03-27
Critical
0
Units
31,921,748

Why these products were recalled

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2019-03-27

    ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk

    ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.

    Product
    FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments,
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2019-03-27

    ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach

    ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.

    Product
    Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forcep
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2019-03-27

    ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk

    ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.

    Product
    Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2019-03-27

    ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach

    ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.

    Product
    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into
    Category
    Distribution
    4 states
ConvaTec, Inc recalled 4 products on 2019-03-27 · The Recall Desk