TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distrib

FDA device recall Z-0720-2014 · posted 2014-01-11 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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

Status

Terminated

Product code

FGX

Quantity affected

425 eaches

Distribution

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

Date initiated

2013-11-20

Date posted

2014-01-11

Date terminated

2015-02-24

Location

Marlborough, MA