Device product
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.
Z-1941-2015
Product summary
- Event
- Event 71137
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-1941-2015
Official wording
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 information: Lot: 17673858
Distribution pattern: Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
Derived failure modes
-
Unknown
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.