510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0978-2009

Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector...

Boston Scientific Corporation / initiated 2008-12-24 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Boston Scientific Corporation began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0978-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
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 nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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.
Root cause tag
packaging
FDA 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 Representative.
Quantity in commerce
15,334
Distribution
Worldwide Distribution.
Product codes and lots
Lot Numbers for UPN M00560100: 9261338, 9283882, 9305162, 9327239, 9369045, 9372244, 9412852, 9451457, 9505237, 9521511, 9592459, 9633852, 9681234, 9722306, 9753577, 9754934, 9754935, 9754936, 9810372, 9824002, 11015389, 11036295, 11057651, 11083694, 11147192, 11204692, 11229075, 11263907, 11320518, 11357567, 11390523, 11394227, 11463699, 11525430, 11544096, 11595300, 11617465, 11661744, 11696754, 11742585, 11767910, 11815749, 11871189, 11899606, 11975822, 12027023 and 12051845.  Lot Numbers for UPN M00560101: 9256060, 9356184, 9473937, 9562330, 9644511, 9774420, 11043881, 11132563, 11194002, 11284265, 11324380, 11460248, 11573667, 11624658, 11716593, 11830799, 11979368 and 12030396.