Recall Z-0108-2015 ยท DYB Introducer, Catheter
St Jude Medical
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.
| Date | Oct 22, 2014 (initiated Oct 14, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | St. Jude Medical sent an Urgent Medical Device Recall Notice dated October 14, 2014, to all affected consignees. The letter described the problem and the product affected by the recall. Advised consignees to discontinue us of the device. A St. Jude Medical sales representative were to contact the consignee in the near future to facilitate removal and reconciliation of the recalled device. Customers with questions were instructed to contact their St. Jude Medical sales Representative. For questions regarding this recall call 651-756-2295. |
| Quantity | 220 |
| Distribution | Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS Daig Corp., Nov 28, 1995 |