Recall Z-0978-2009 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleedi
| Date | Feb 13, 2009 (initiated Dec 24, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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 R |
| Quantity | 15,334 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.