AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
FDA Recall Z-2176-2017 · Posted None
Recalling FirmAbbVie Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-04-27
Date Terminated2019-07-09
Product Quantity673 kits
Firm Action
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.
Root Cause
Under Investigation by firm
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.