Z-0108-2015 Class II Terminated
FDA device recall Z-0108-2015 was initiated by St Jude Medical on Oct 14, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 25, 2015). Affected quantity: 220.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 29, 2014
- Initiation Date
- Oct 14, 2014
- Termination Date
- Mar 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 220
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
Code Information
Batch 4641580
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0108-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026