Recall Z-0810-2011
Boston Scientific Corporation · initiated October 20, 2010
Product
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Codes / lots: Lot/Batch Numbers: 7441839 and 7442099.
Reason for recall
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
FDA-determined cause: Other
Action taken
"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.
Details
- Recall number
- Z-0810-2011
- Initiated
- October 20, 2010
- Posted by FDA
- December 27, 2010
- Terminated
- August 3, 2011
- Product code
- FCG – Biopsy Needle
- Quantity
- 567 all products
- Distribution
- Worldwide Distribution -- US and Canada.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0809-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | 10/20/2010Terminated |
| Z-0811-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm)…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | 10/20/2010Terminated |
| Z-0812-2011 | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm)…The firm has received a high number of complaints related to difficulty advancing and/or retracting the… | 10/20/2010Terminated |