Avanos MIC Percutaneous Gastrostomy Kit Recalled for Bolster Sizing Defect
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy PEG Kit because the external retention bolster may be larger than the tube, creating a risk of improper fit and potential device failure.
What this means for you
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: FDA Class II medical device recall involving a structural sizing defect in a critical feeding and medication delivery component. This qualifies as a risk-of-harm product where no injuries have been reported, meeting the High severity criterion.
Plain-English summary
Avanos Medical, Inc. is recalling the MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors (20 Fr-PULL model). The recalled kits were distributed worldwide, including across the United States, Canada, and Chile.
The external retention bolster contained in these kits may be a larger diameter than the tube. This sizing defect could result in improper fit between the bolster and tube, potentially leading to device failure or disconnection during use. The defect affects 692 units with the following lot codes: Code 8160-20 Lot 30135103 and Code 8640-20 Lot 30132544.
Patients or healthcare providers using affected PEG kits should contact their healthcare provider or Avanos Medical for instructions on whether replacement or inspection is needed. Do not discontinue use of the device without medical guidance, as this could interrupt essential nutrition or medication delivery.
The recalled product
- Product
- MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- improper-fit
- disconnection-risk
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 (3)
- 1) Code 8160-20
- Lot 30135103 2) Code 8640-20
- Lot 30132544
Distribution
Distributed nationwide across the United States.
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