St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Int

FDA device recall Z-0108-2015 · posted 2014-10-22 · Terminated

Recall details

Recalling firm

St Jude Medical

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

DYB

Quantity affected

220

Distribution

Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.

Date initiated

2014-10-14

Date posted

2014-10-22

Date terminated

2015-03-25

Location

Saint Paul, MN

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