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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific PLUS

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 Class 2 Device Recall Boston Scientific PLUSsee related information
Date Initiated by FirmNovember 20, 2013
Date PostedJanuary 11, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-0721-2014
Recall Event ID 66907
Product Classification Snare, non-electrical - Product Code FGX
ProductTWISTER 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.
Code Information Lot Numbers: H13061101, H13062403, H13062404, H13071301
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactSame
508-382-9555
Manufacturer Reason
for Recall		Sterility of device may be compromised due to lack of pouch seal integrity
FDA Determined
Cause 2		Packaging process control
ActionBoston 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.
Quantity in Commerce740 eaches
DistributionWorldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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