Recall Z-0786-2017 ยท KNT Tubes, Gastrointestinal (And Accessories)
AbbVie Inc.
AbbVie PEG Kit 20 FR
| Date | Nov 22, 2016 |
| Status | Terminated |
| Reason | AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors. |
| Root cause | Device Design |
| Action | The firm sent an URGENT: MEDICAL DEVICE FIELD CORRECTION NOTIFICATION AbbVie PEG Kit 20 FR to affected customers describing the reason for the notification. The letter asks affected customers to forward this letter to all Movement Disorder Specialists and physicians (e.g. GIs, IRs, and surgeons) that place PEG- J Tubes within your facility. The letter describes actions to be taken for patients still using the AbbVie PEG 20FR Tube. The letter requests user facilities to continue to monitor the performance of the Tube. The firm states that there is no need to replace the AbbVie PEG 20FR Tub |
| Quantity | 541 units |
| Distribution | U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142793 | AbbVie PEG AbbVie , Inc., Jan 14, 2015 |