FDAFDA · Food and drugs·Recall number Z-0108-2015
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
Published October 29, 2014 · Recall initiated: October 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical
- Distributor
- Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
- Lot
- Batch 4641580
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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