Avanos Medical, Inc.: MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

Recall number

Z-1187-2024

Recalling firm

Avanos Medical, Inc.

Product

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-15; c) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-22; d) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16-30; e) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18; f) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-22; g) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 18 Fr, Product Code 0250-18-30; h) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 22 Fr, Product Code 0250-22; i) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 16 Fr, Product Code 0260-16; j) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 18 Fr, Product Code 0260-18; k) MIC* Gastric-Jejunal Feeding Tube Kit - Surgical Placement - 22 Fr, Product Code 0260-22;

Status

Open, Classified

Initiated

2024-01-16

Posted

2024-03-01

Terminated

not on file

Reason

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

Root cause

Nonconforming Material/Component

Action

AVANOS MEDICAL, INC. issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 01/16/2024 via FedEx. The notice explained the issue, the potential risk to health, and requested the following actions be taken: " Please continue to perform normal post op care for any newly placed MIC GJ tube. Per the Daily Care & Maintenance Check List found in the product Instructions for Use: o Assess the patient for any signs of pain, pressure or discomfort. o Assess the stoma site for any signs of infection, such as redness, irritation, edema, swelling, tenderness, warmth, rashes, purulent, or gastrointestinal drainage. o Assess the patient for any signs of pressure necrosis, skin breakdown, or hypergranulation tissue. " Report any adverse events involving these products immediately to PIQ@avanos.com " Check all storage facilities and warehouse locations for affected products and quarantine them. " Complete the Customer Response Form. which can be found online: https://iqvia-response.my.site.com/mt/fca?cid=avanos-fca-2024-001, or by using the QR code provided in the Field Correction Acknowledgement Instructions accompanying this letter. " Destroy all affected lots in your inventory per your facility s procedures o Alternatively if you are unable to destroy your affected inventory, please indicate so on the form and you will be provided information on how to return product for destruction. o A refund will be provided to you based on the quantity of affected product you have indicated on the Customer Response Form. " Distributors only: alert your affected customers of this recall. We ask that you work with them to destroy affected product and provide them refunds as per your internal processes. Provide to Avanos an updated response using the Customer Response Form to receive refunds or credit for your customers affected products. " Please reach out to avanos-fca-2024-001@iqvia.com or call (855) 201-1355 with any questions or concerns regarding these instructions.

Quantity

53126 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.

Lot, serial or model codes

a) Product Code 0250-16, UDI/DI 00350770954806, Batch Numbers: 30180718, 30181870, 30184758, 30186768, 30194327, 30226669, 30226817, 30229831, 30240299, 30244886, 30248036, 30248348, 30251106, 30251988, 30254746, 30258134, 30267592; b) Product Code 0250-16-15, UDI/DI 00350770954813, Batch Numbers: 30185370, 30194326, 30249243, 30256710; c) Product Code 0250-16-22, UDI/DI 00350770954820, Batch Numbers: 30226808, 30238975; d) Product Code 0250-16-30, UDI/DI 00350770954837, Batch Numbers: 30184813, 30186749, 30190699, 30226816, 30235093, 30245070; e) Product Code 0250-18, UDI/DI 00350770954844, Batch Numbers: 30181844, 30181869, 30184757, 30185369, 30186748, 30189492, 30190698, 30195869, 30226668, 30226815, 30228967, 30229830, 30238122, 30238885, 30239857, 30238982, 30240298, 30240451, 30243197, 30242224, 30244885, 30250139, 30251984, 30254745, 20108481, 30256210, 30256482, 30257069, 30258133, 30259563, 30261698, 30262037, 30264281, 30267591, 30268254, 30270503, 30270858; f) Product Code 0250-18-22, UDI/DI 00350770954851, Batch Numbers: 30186747, 30188504, 30226814, 30238981, 30248034, 30253948, 30256709; g) Product Code 0250-18-30, UDI/DI 00350770954868, Batch Numbers: 30181868, 30184756, 30185379, 30186767, 30189491, 30190697, 30194325, 30195868, 30200971, 30226813, 30228966, 30229829, 30238121, 30240450, 30244884, 30248033, 30248345, 30254744, 30259562; h) Product Code 0250-22, UDI/DI 00350770954875, Batch Numbers: 30178410, 30181843, 30181867, 30184755, 30185368, 30195736, 30192113, 30195735, 30198033, 30226667, 30226812, 30228965, 30231399, 30238120, 30238512, 30238980, 30240484, 30240297, 30240449, 30250138, 30250166, 30252990, 30253947, 30254743, 30256209, 30256481, 80402126, 80402127, 30257064, 30259561, 30261697, 30262036, 30268253, 30270502, 30270857; i) Product Code 0260-16, UDI/DI 00350770954882, Batch Numbers: 30195867, 30245069, 30258131, 30267590; j) Product Code 0260-18, UDI/DI 00350770954899, Batch Numbers: 30181880, 30185383, 30195858, 30238884, 30239856, 30244880, 30250593, 30250160, 30262027, 30290826; k) Product Code 0260-22, UDI/DI 00350770954905, Batch Numbers: 30180717, 30186745, 30236828, 30238511, 30250165, 30259560, 30265343, 30290827

510(k) numbers

["K921370"]

PMA numbers

not on file

Product code

KNT

Firm FEI

3011270181

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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