Boston Scientific Corporation recalls TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Dist

Recalled January 22, 2014 · FDA recall Z-0723-2014 · Boston Scientific

Hazard

Sterility of device may be compromised due to lack of pouch seal integrity · FDA Class II

Units

620 eaches

Sold at

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

Description

Sterility of device may be compromised due to lack of pouch seal integrity

Product

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.

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →