Recall Z-1630-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
Boston Scientific Corp
Boston Scientific EndoVive 20F (6.7 mm) Standard PEG Kit, Push Method, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6821, inner pouch UPN M00568210 and outer carton UPN M00568211. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
| Date | May 5, 2009 |
| 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 | Process control |
| Action | Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678. |
| Quantity | 4276 |
| Distribution | Worldwide Distribution -- United States, India, Japan and Slovenia. |
| 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 |