FDA (Devices) recall action 77129
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
AbbVie is recalling specific lots of PEG Kits due to potential defects including missing components, duplicate parts, or missing labels and instructions.
AbbVie is recalling 3,331 PEG kits distributed in the US and 31 other countries because they may have missing components, duplicate parts, or missing labels.
AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.