—#103539

Product

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.

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100712, K110030
Affected lot / code info: Lot: 13615651C1; UPN M00550020

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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) following the directions on this page and Reply Verification Tracking Form. Fax the Form to (508) 683-5578. Further questions please call (508) 683-4678.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.

Timeline

Recall initiated: 2011-08-11
Posted by FDA: 2011-09-16
Terminated: 2011-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.