Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. For Single

FDA device recall Z-0977-2009 · posted 2009-02-13 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.

Action taken

A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.

Root cause

Packaging process control

Status

Terminated

Product code

KNS

Quantity affected

83,435

Distribution

Worldwide Distribution.

Date initiated

2008-12-24

Date posted

2009-02-13

Date terminated

2010-05-11

Location

Miami, FL