Avanos Medical, Inc.: MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Missing Risk Information

What You Should Do

1. Identify if you have an affected MIC-KEY Gastric-Jejunal (GJ) Feeding Tube Kit by checking the reference numbers and UDI-DI codes on the product packaging. Affected models include REF 0270xx (Non-ENFit) and REF 8270xx (ENFit) kits.
2. For 14 Fr models, check for UDI-DI codes such as 00350770472171, 00350770470207, and others listed in the product details across all lot numbers.
3. For 16 Fr models, verify if your kit matches UDI-DI codes like 00350770954912 or 00350770441719.
4. For 18 Fr and 22 Fr models, check for identifying codes including 00350770956503, 00350770956695, and 00350770441023.
5. Contact your healthcare provider to discuss the missing risk information in the Instructions for Use and to determine if any changes to your care or device monitoring are necessary.
6. Contact Avanos Medical, Inc. directly at their Alpharetta, Georgia headquarters or through their official website to receive the updated Instructions for Use or further safety guidance.
7. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products