Recall Z-0971-05 ยท KGC Tube, Gastro-Enterostomy
Boston Scientific Corp
Boston Scientific brand One Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852.
| 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
| K910584 | ONE STEP BUTTON(TM) Applied Medical Technologies, May 23, 1991 |