Device product
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Z-0721-2014
Product summary
- Event
- Event 66907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 740 eaches
- Official record key
device-enforcement:Z-0721-2014
Official wording
Reason: Sterility of device may be compromised due to lack of pouch seal integrity
Code information: Lot Numbers: H13061101, H13062403, H13062404, H13071301
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
Derived failure modes
-
Unknown
Sterility of device may be compromised due to lack of pouch seal integrity