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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Boston Scientific TWISTER® PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Recall Number Z-0719-2014
Classification Class II
Code Info Lot Numbers: H13061101, H13062403, H13062404, H13071301
Product Distributed Qty 0 eaches
Reason For Recall Sterility of device may be compromised due to lack of pouch seal integrity

Event Detail

Event Id 66907
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Marlborough
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
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