Device Recall Boston Scientific

Lot Numbers: H13061101, H13062403, H13062404, H13071301

Gastroenterology-Urology Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

TWISTER PLUS 22mm Rotatable || Retrieval Device (Box of 5 configuration) || Universal Product Number (UPN): M00561411. || Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. || Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

Lot Numbers: H13061101, H13062403, H13062404, H13071301

Gastroenterology-Urology Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

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.

Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13062402, H13071302, H13082603

Gastroenterology-Urology Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

TWISTER PLUS 26mm Rotatable Retrieval Device || (Box of 1 configuration) || Universal Product Number (UPN):M00561420. || 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.

Lot Numbers: H13061102, H13061103, H13061104, H13062401, H13082603

Gastroenterology-Urology Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

TWISTER PLUS 26mm Rotatable Retrieval Device || (Box of 5 configuration) || Universal Product Number (UPN):M00561421. || 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.

Lot Numbers: H13061102, H13061104, H13062401, H13062402, H13071302, H13082603

Gastroenterology-Urology Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.

TWISTER PLUS 26mm Rotatable Retrieval Device || (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. || Universal Product Number (UPN):M00561422 || Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.