The Recall Desk

FDA (Devices) recall action 66234

Smiths Medical ASD, Inc. recalled 2 products on 2013-10-02

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
2013-10-02
Critical
0
Units
562

Why these products were recalled

Smiths Medical is conducting a voluntary recall of PORT-A-CATH¿ and PORT-A-CATH¿ II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets. Smiths Medical has received no reports

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

1–2 of 2

  • ModerateFDA (Devices)··2013-10-02

    Smiths Medical Recalls PORT-A-CATH Introducer Sets Due to Sizing Issues

    Smiths Medical is voluntarily recalling PORT-A-CATH Introducer Sets because the sheath opening may be too small for the catheter width.

    Product
    Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of…
    Category
    Distribution
    25 states
  • ModerateFDA (Devices)··2013-10-02

    Smiths Medical Recalls Port-A-Cath Venous Access Systems Due to Sizing Issue

    Smiths Medical is voluntarily recalling Port-A-Cath and Port-A-Cath II implantable venous access systems and introducer sets because the introducer sheath opening may be too small for the catheter.

    Product
    Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable…
    Category
    Distribution
    25 states