Recall Z-2237-2008 ยท KNT Tubes, Gastrointestinal (And Accessories)
Boston Scientific Corporation
EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
| Date | Sep 17, 2008 (initiated Jun 17, 2008) |
| Status | Terminated |
| Reason | Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG |
| Root cause | Labeling mix-ups |
| Action | Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance. |
| Quantity | 16 Kits (total number of Kits) |
| Distribution | NJ, SC, TN, VA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030855 | MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT Boston Scientific Corp, Apr 17, 2003 |