Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
Avanos Medical included lidocaine hydrochloride injections with quality defects in 234 sterile PEG kits. The injections were already the subject of a supplier recall. The kits affected are model 8170-24 in specific lot numbers distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have one of the affected lot numbers: 30371847, 30374834, 30378748, or 30380347.
- Contact Avanos Medical or your healthcare facility if you have one of these kits.
- Do not use the lidocaine injection included in affected kits.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 20 products — see all of them.
Details
- Units affected
- 234 kits
- Illnesses reported
- None reported
- Manufactured in
- 5405 Windward Pkwy, N/A, Alpharetta, GA, United States
- Classification
- Class II
- Recall number
- Z-2349-2026
In the FDA's words
- Description
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24 Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. UDI-DI 10350770007837, Lot Numbers 30371847, 30374834, 30378748, 30380347 Distribution: US Nationwide distribution. Affected quantity: 234 kits
- Hazard
- Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
20 products in this recall
Avanos CORFLO, MIC PEG kits recalled for lidocaine quality issue
Avanos Medical is recalling 20 PEG feeding tube kits sold under the CORFLO and MIC Safety names. The kits were made with lidocaine hydrochloride injection that is itself subject to a supplier recall for quality issues. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320Z-2333-2026 · 231 kits
- Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320Z-2334-2026 · 61 kits
- Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312Z-2335-2026 · 31 kits
- Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316Z-2336-2026 · 41 kits
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320Z-2337-2026 · 49 kits
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320Z-2338-2026 · 72 kits
- Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312Z-2339-2026 · 43 kits
- Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: NoZ-2340-2026 · 54 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube KitZ-2341-2026 · 22 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit…Z-2342-2026 · 901 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit…Z-2343-2026 · 132 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14Z-2344-2026 · 208 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20Z-2345-2026 · 3,184 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24Z-2346-2026 · 1,006 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Descripti…Z-2347-2026 · 53 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20Z-2348-2026 · 1,615 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24 (this page)Z-2349-2026 · 234 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14Z-2350-2026 · 218 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20Z-2351-2026 · 6,005 kits
- Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24Z-2352-2026 · 1,205 kits