United StatesAvanos Medical CORFLO and MIC Safety PEG feeding tube kits (including CORFLO models/catalog numbers 30-4320, 30-5320, 30-6312, 30-6316, 50-4320, 50-5320, 50-6312, 50-6316 and multiple MIC models such as 7170, 7180, 8170, and others) with the listed UDI-DIs and lot numbers distributed nationwide are affected. They were recalled because lidocaine hydrochloride injection, which was the subject of a supplier recall for quality issues, was included in the sterile kits and sets.
What's being recalled
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312
Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320
Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312
Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No
And 5 more products.
Recalling firm: Avanos Medical, Inc., Alpharetta, GA, United States.
How to identify it
UDI-DI 10350770007585, Lot Numbers 30365226 and 30382750 UDI-DI 10350770007554, Lot Numbers 30365227, 30368642, 30374529, 30376099, 30380696, and 30387248 Lot Code: Model No 30-6312, UDI-DI 10350770007547, Lot Number 30365228 Lot Code: Model No 30-6316, UDI-DI 10350770007561, Lot Numbers 30365229 and 30376100 UDI-DI 10350770007578, Lot Numbers 30365230, 30367013, 30373825 UDI-DI 10350770007516, Lot Numbers 30365231, 30371022, 30373824, 30378385, 30383807, 30385321 UDI-DI 10350770007523, Lot Numbers 30365232, 30367019, 30380107 UDI-DI 10350770007530, Lot Numbers 30365233, 30367015, 30372821, 30378386 UDI-DI 10350770007752, Lot Number 30370713 Lot Code: Model No 7170-20, UDI-DI 10350770007776, Lot Numbers 30370714, 30373419, 30374048, 30378746 UDI-DI: 10350770007790, Lot Numbers 30370715, 30371329, 30375466 UDI-DI 10350770007769, Lot Numbers 30371312 and 30373421 UDI-DI 10350770007783, Lot Numbers 30371313, 30371314, 30373295, 30373296, 30374832, 30378735, 80403340 UDI-DI 10350770007806, Lot Numbers 30371316, 30377829, 80403341 UDI-DI 10350770007813, Lot Number 30370718 UDI-DI 10350770007820, Lot Numbers 30371324, 30374833, 30384889, 80403350 UDI-DI 10350770007837, Lot Numbers 30371847, 30374834, 30378748, 30380347 UDI-DI 10350770007844, Lot Numbers 30371318, 30375469, 30383056 Lot Code: Model No 8180-20, UDI-DI 10350770007851, Lot Numbers 20133232, 30371326, 30378749, 30378751, 30379686, 30383063, 30383057, 80403339, 80403342 UDI-DI 10350770007868, Lot Numbers 30371319, 30374055, 30383058, 30386936
The hazard
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada