Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Recall
- Recall Number
- Z-0811-2011
- Event Number
- 57317
- Firm
- Boston Scientific Corporation
- FEI Number
- 3005099803
- Product Code
- FCG
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 20, 2010
- Posted
- December 27, 2010
- Terminated
- August 3, 2011
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234
Description
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
"Urgent Medical Device Recall - Immediate Action Required" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, 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 as a method of documenting the presence or absence of affected product from their inventory.
Worldwide Distribution -- US and Canada.
567 all products.