Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex fre
FDA device recall Z-0914-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Action taken
- Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 2460 of all products
- Distribution
- Nationwide.
- Date initiated
- 2008-12-30
- Date posted
- 2009-01-28
- Date terminated
- 2009-10-30
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT (K031538) | Boston Scientific Corp | 2003-06-27 |