FDA Medical Device Recalls (openFDA)
AbbVie Inc.: AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Recall number
- Z-2177-2017
- Recalling firm
- AbbVie Inc.
- Product
- AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Status
- Terminated
- Initiated
- 2017-04-27
- Posted
- not on file
- Terminated
- 2019-07-09
- 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.
- Quantity
- not on file
- 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, serial or model codes
- Material/List number: 629100116 Lots: 32025235, 32184275, 32354106, 32365305, 32435265
- 510(k) numbers
- ["K142793"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3009751352
- Firm city
- North Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28