Recall Z-2177-2017 ยท KNT Tubes, Gastrointestinal (And Accessories)
AbbVie Inc.
AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
| Date | Apr 27, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142793 | AbbVie PEG AbbVie , Inc., Jan 14, 2015 |