Z-0786-2017 Class II Terminated
FDA device recall Z-0786-2017 was initiated by AbbVie Inc. on November 22, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 9, 2019). Affected quantity: 541 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Termination Date
- July 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 541 units
Product Description
AbbVie PEG Kit 20 FR
Reason for Recall
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.
Distribution Pattern
U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
Code Information
AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336