MIC Percutaneous Endoscopic Gastrostomy Kits Recalled for Oversized Retention Bolster
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.
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: This is an FDA Class II recall involving a manufacturing defect in a medical device. No illnesses or injuries have been reported. Per the rubric, 'risk-of-harm products where injury has not yet been reported' score 3 (High).
Plain-English summary
Avanos Medical, Inc. is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit (20 Fr-PULL model).
The external retention bolster contained in the kit may be a larger diameter than the tube. This manufacturing condition prompted the recall.
The recall affects 2,652 units with specific lot codes: Code 7160-20 (Lots 30116959, 30132543, 30132545, 30132546) and Code 7640-20 (Lot 30129345). The affected kits were distributed in the United States, Canada, and Chile.
Patients using this kit should contact their healthcare provider for guidance. Healthcare providers and consumers with questions can contact Avanos Medical or the FDA.
The recalled product
- Product
- MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
- Manufacturer
- Avanos Medical, Inc.
- Hazard
- manufacturing-defect
- improper-sizing
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 (6)
- 1) Code 7160-20
- Lots 30116959
- 30132543
- 30132545
- and 30132546 2) Code 7640-20
- Lots 30129345
Distribution
Distributed nationwide across the United States.
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