AbbVie Recalls PEG Kits Due to Missing or Duplicate Components
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.
What this means for you
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, and the defects involve missing or duplicate components and labeling errors. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving potential misuse or administrative errors.
Plain-English summary
AbbVie Inc. is recalling 3,331 units of the PEG Kit 15FR, a sterile medical device intended for enteral use. The recall is due to potential defects in the kits, which may include missing components, duplicate components, or missing labels and Instructions for Use that contain expiry information.
The affected product is identified by Material/List number 62918001 and lots 32044225, 32155205, 32344326, and 32461215. The kits were distributed nationwide in the United States as well as in 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.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product matches the recalled description, it should be removed from use and returned to the supplier or the manufacturer for further instructions.
The recalled product
- Product
- AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
- Manufacturer
- AbbVie Inc.
- Affected units
- 3,331
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 (4)
- Material/List number: 62918001 Lots: 32044225
- 32155205
- 32344326
- 32461215
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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