Recall Z-0911-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
Boston Scientific Corp
Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventiona
| Date | Jan 28, 2009 (initiated Dec 30, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2460 of all products |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031538 | ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT Boston Scientific Corp, Jun 27, 2003 |