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Terminated

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.

FDA Recall Z-0721-2014 · Posted 2014-01-11

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGX
Date Initiated2013-11-20
Date Terminated2015-02-24
Product Quantity740 eaches

Reason for Recall

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

Firm Action

Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

Root Cause

Packaging process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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