FDA-Device2014-01-22Class II
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.
Boston Scientific Corporation
Hazard
Sterility of device may be compromised due to lack of pouch seal integrity
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
Affected count
425 eaches
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2014Don't want to check this manually?
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