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St Jude Medical recalls St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis
Recalled October 29, 2014 · FDA recall Z-0108-2015 · St Jude Medical
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. · FDA Class II
Units
220
Sold at
Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
Description
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.
Product
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.
Manufacturer(s)
St Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →