AbbVie Recalls PEG Kits Due to Missing or Duplicate Components
AbbVie is recalling specific lots of PEG Kits due to potential defects including missing components, duplicate parts, or missing labels and instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defects involve missing or duplicate components and missing labels, which are quality control issues that could lead to improper use but do not explicitly report injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AbbVie Inc. is recalling specific lots of PEG Kits (15FR, for enteral use only, sterile, Rx Only). The recall is due to the potential for defects in the kits, which may include missing components, duplicate components, or missing labels and Instructions for Use. The missing labels may include expiry information.
The affected product is distributed nationwide and in numerous international locations, including 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, and Turkey. The specific lots affected are 32025235, 32184275, 32354106, 32365305, and 32435265, associated with material/list number 629100116.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to AbbVie's instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Manufacturer
- AbbVie Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Material/List number: 629100116 Lots: 32025235
- 32184275
- 32354106
- 32365305
- 32435265
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AbbVie Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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