FDAClass IMarch 13, 2024

MIC* Gastric-Jejunal Feeding Tube with ENFit recall

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic…

Why was MIC* Gastric-Jejunal Feeding Tube with ENFit recalled?

MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers: 30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862; b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers: 30226822, 30242228, 30253956; c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers: 30184814, 30226821, 30247088, 30253955, 30262508, 30226820; d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers: 30231400, 30238125 30247087, 30250300, 30258135, 30265373; e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers: 30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505; f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers: 30184824, 30228970, 30240302, 30247094, 30257066; g) Product Code 8250-18-30, UDI/DI 00350770445472, Batch Numbers: 30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861; h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers: 30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860; i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers: 30181845, 30223861, 30256484, 30290828; j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers: 30185408, 30233438, 30242225, 30259226, 30264282, 30290830; k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers: 30256483, 30259564, 30290829

Product
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic…
Recalling firm
Avanos Medical, Inc.
Quantity
10808 units
Distribution
Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.
Recall date
March 13, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls