Recall Z-3215-2011 ยท FCG Biopsy Needle
Boston Scientific Corporation
Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
| Date | Sep 16, 2011 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga. |
| Root cause | Other |
| Action | Boston Scientific Corporation sent a "URGENT MEDICAL DEVICE RECALL letter dated August 11, 2010, to all affected customers. The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to immediately remove the affected lot of Recall products from your inventory ( whether in Labs, Central Supply, Shipping and Receiving or any other location). Also, segregate this product in a secure location for return to Boston Scientific. Complete and return the Reply Verification Tracking Form ( even if you do not have any product to return) fol |
| Quantity | 30 units |
| Distribution | Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN. |
| FDA record | Open on fda.gov |