Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 ST
FDA device recall Z-3215-2011 · posted 2011-09-16 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 30 units
- Distribution
- Nationwide Distribution including the states of VT, FL, SC, NC, WA, MA, and MN.
- Date initiated
- 2011-08-11
- Date posted
- 2011-09-16
- Date terminated
- 2011-11-10
- Location
- Marlborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPECT ENDOSCOPIC ASPIRATION NEEDLE (K110030) | Boston Scientific Corp | 2011-01-12 |
| RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K100712) | Boston Scientific Corporation | 2010-03-30 |