FDA Enforcement
Class II
Terminated
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Recall: Z-1941-2015
·
Reported July 8, 2015
Enforcement
- Recall Number
- Z-1941-2015
- Event ID
- 71137
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2015
- Initiation Date
- April 27, 2015
- Classification Date
- June 30, 2015
- Termination Date
- January 27, 2016
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States
Description
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Reason
One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Code Info
Lot: 17673858
Distribution
Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
Quantity
39 units