The Recall Desk

FDA (Devices) recall action 67588

Convatec Inc. recalled 6 products on 2014-03-26

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-03-26
Critical
0
Units
100,580

Why these products were recalled

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

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

1–6 of 6

  • HighFDA (Devices)··2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.

    Product
    Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 31,250 latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-03-26

    Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

    Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-03-26

    Medline Sterile Foley Catheter Recalled for Blocked Lumen

    Convatec Inc. is recalling Medline Sterile Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-03-26

    Convatec SLC Foley Catheters Recalled for Blocked Lumens

    Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.

    Product
    SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-03-26

    Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Distribution
    1 state