Agency classClass IIOur severity:High FDA (Devices)·Z-2176-2017·Announced 2017-06-07

AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.

Plain-English summary

AbbVie Inc. is voluntarily recalling 673 kits of AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. The recall was initiated on April 27, 2017, and was classified as Class II by the FDA. The specific reason for the recall is not detailed in the source text, but the product is labeled as sterile, implying a potential sterility failure.

The affected lots are 32025245, 32054247, 32265215, 32335206, and 32335336, associated with Material/List number 629100116. These kits were distributed nationwide in the United States as well as 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 recall status is currently Terminated, with a termination date of July 9, 2019. Affected parties were notified via letter. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and stop using the product if it matches the recalled description.

The recalled product

Product: AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Manufacturer: AbbVie Inc.
Category: Medical Device — Enteral Feeding
Hazard: sterility-failure
Affected units: 673

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: 32025245
32054247
32265215
32335206
32335336

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.

See all 3 products in this recall →

Same manufacturer · AbbVie Inc.

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