Recall Z-0963-05 ยท KGC Tube, Gastro-Enterostomy
Boston Scientific Corp
Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, pull; catalog number 6820.
| Date | Jul 7, 2005 (initiated Jun 2, 2005) |
| Status | Terminated |
| Reason | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Root cause | Other |
| Action | Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand. |
| Distribution | Nationwide and Panama. |
| 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 |