Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

FDA Recall Z-2177-2017 · Posted None

Recalling FirmAbbVie Inc.
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-04-27
Date Terminated2019-07-09

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.

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.

↑