FDA-Device2026-06-17Class IIPROCESSING DEFECT
Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
What this means
Avanos Medical included lidocaine hydrochloride injections with quality issues in their MIC Safety Percutaneous Endoscopic Gastrostomy (PEG) kits. The lidocaine was subject to a supplier recall for quality defects. About 6,000 kits were distributed nationwide.
- Check if you have a MIC Safety PEG Kit (20 Fr, Model 8180-20) with one of the affected lot numbers: 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, or 80403342.
- Do not use the lidocaine injection included in the kit.
- Contact Avanos Medical or your healthcare provider for guidance on obtaining replacement kits or alternative lidocaine.
The agency's original wording
Hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
6,005 kits
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2351-2026Want us to check the next one for you?
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