Recall Z-0108-2015— St Jude Medical

Name: FDA recall Z-0108-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-14

Class II · Terminated

Class II FDA medical device recall by St Jude Medical, initiated 2014-10-14, terminated 2015-03-25. It names one FDA 510(k) clearance: K954317. 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.. 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..

Recalling firm: St Jude Medical
Classification: Class II
Status: Terminated
Initiated: 2014-10-14
Terminated: 2015-03-25
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K954317 — DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDaig Corp.·cleared 1995-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.