AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Company
- Abbvie Inc.
- Recall Initiated
- April 27, 2017
- Terminated
- July 9, 2019
- Recall Number
- Z-2178-2017
- Quantity
- 3,331 kits
- Firm Location
- North Chicago, IL
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
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
Lot / Code Info
Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215
Root Cause
Under Investigation by firm
Action Taken
On April 27, 2017, firm sent letter (and response form) to customers, instructing them to inspect their inventory for affected lots and arrange a replacement kit to be delivered by AbbVie if a kit with missing components is discovered. Distributors were asked to notify their customers. Any returned affected product will be destroyed.