Recall Z-0402-2016 ยท KGC Tube, Gastro-Enterostomy
Boston Scientific Corp
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
| Date | Dec 10, 2015 (initiated Sep 11, 2015) |
| Status | Terminated |
| Reason | Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific Corp. sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated September 10, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you identify any product from the affected lot within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed recall instructions. You will receive replacements for all recalled product that is returned to Boston Scientific. If you are a distributor, or hosp |
| Quantity | 22 units |
| Distribution | US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910584 | ONE STEP BUTTON(TM) Applied Medical Technologies, May 23, 1991 |