Z-1187-2024Class I

MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding...

Name: Z-1187-2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding...
Creator: Avanos Medical, Inc.
Published: 2024-01-16
License: https://open.fda.gov/license/

Halyard Health / initiated 2024-01-16 / Open, Classified / root cause: manufacturing process

FDA source

Avanos Medical, Inc. began a recall of MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16... on 2024-01-16. FDA classified it as Class I and gives the reason as "MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1187-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-01-16
Posted: 2024-03-01
Recalling firm: Halyard Health
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;
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Root cause tag: manufacturing process
FDA 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 [email protected] " 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 [email protected] or call (855) 201-1355 with any questions or concerns regarding these instructions.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1187-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01
Z-1187-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-01

Product code KNT

K921370Class IIMic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. / cleared 1994-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)