Z-2178-2017 Class II Terminated
FDA device recall Z-2178-2017 was initiated by AbbVie Inc. on April 27, 2017 and is designated Class II. Reason for recall: PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information. The recall status is terminated (terminated July 9, 2019). Affected quantity: 3,331 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 27, 2017
- Termination Date
- July 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,331 kits
Product Description
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Reason for Recall
PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
Distribution Pattern
Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey
Code Information
Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215