Recall Z-0721-2014— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2013-11-20, terminated 2015-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Sterility of device may be compromised due to lack of pouch seal integrity.
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2015-02-24
- Firm location
- Marlborough, MA, United States
Product description
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.
Reason for recall
Sterility of device may be compromised due to lack of pouch seal integrity
Data sourced from openFDA. This site is unofficial and independent of the FDA.