Z-2422-2024Class II

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx...

Name: Z-2422-2024 MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx...
Creator: Avanos Medical, Inc.
Published: 2024-05-31
License: https://open.fda.gov/license/

Halyard Health / initiated 2024-05-31 / Open, Classified / root cause: labeling and UDI

FDA source

Avanos Medical, Inc. began a recall of MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding... on 2024-05-31. FDA classified it as Class II and gives the reason as "The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2422-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-07-23
Recalling firm: Halyard Health
Product: MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The recalling firm issued separate letters to distributors and customers on and dated 5/31/2024 via email and FedEx. The letter advised them the firm has updated the IFU to include additional complications associated with the use of the AVANOS MIC-KEY* Gastric-Jejunal Feeding Tubes which is supplied with the product and provides users and patients information about the intended purpose, proper use, and risks associated with the use of the device. The letter outlined the risk information pertaining to potential complications for the affected devices listed in the letter. The letter contains a QR code for the distributor or customer to access for an electronic version of the updated IFU. A Field Correction Acknowledgment form was enclosed with the distributor and customer letters for completion and return within 3 business days upon receipt of the notification. It contains a QR code to be scanned to acknowledge receipt of the notice and to complete the customer response form online. Distributors were requested to inform their customers regarding the notification and to provide them a copy of the undated Distributor Customer Letter which outlines much of the same information that is contained in the distributor and customer notification letter.
Quantity in commerce: 53,384 kits
Distribution: Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.
Product codes and lots: All lot numbers. UDI-DI numbers: 1. 0270-14: 00350770472171, 00350770472188, 00350770472195, 00350770472201, 00350770472225, 00350770472232, 00350770472249, 00350770472256, 00350770472263, 00350770472270, 00350770472287, 00350770472294, 00350770472300, 00350770472317, 00350770472331, 00350770472348, 00350770472355, 00350770472362, 00350770472379, 00350770472386, 00350770472393, 00350770472409, 00350770472423, 00350770472416, 00350770479231, 00350770479279, 00350770479262, 00350770479255, and 00350770479293; 2. 0270-16: 00350770954912, 00350770954929, 00350770954936, 00350770954943, 00350770954950, 00350770954967, 00350770954974, 00350770954981, 00350770954998, 00350770956350, 00350770956367, 00350770956374, 00350770956381, 00350770956398, 00350770956404, 00350770956411, 00350770956428, 00350770956435, 00350770956442, 00350770956459, 00350770956466, 00350770956473, 00350770956480, 00350770956497, 00350770479309, 00350770479316, 00350770479323, 00350770479385, and 00350770479354; 3. 0270-18: 00350770956503, 00350770956510, 00350770956527, 00350770956534, 00350770956541, 00350770956558, 00350770956565, 00350770956572, 00350770956589, 00350770956596, 00350770956602, 00350770956619, 00350770956626, 00350770956633, 00350770956640, 00350770956657, 00350770956664, 00350770956671, 00350770956688, 00350770479347, 00350770479330, 00350770479392, 00350770479408, 00350770479415, 00350770479422, and 00350770479439; 4. 0270-22: 00350770956695, 00350770956701, 00350770956718, 00350770956725, 00350770956732, 00350770956749, 00350770956756, 00350770956763, 00350770479446, 00350770479453, 00350770479460, 00350770479477, 00350770479484, and 00350770479491, 00350770479514; 5. 8270-14: 00350770470207, 00350770470238, 00350770470245, 00350770470320, 00350770470351, 00350770470368, 00350770470375, 00350770470382, 00350770470399, 00350770470405, 00350770470412, 00350770470429, 00350770470436, 00350770470450, 00350770470467, 00350770470474, 00350770470481, 00350770470498, 00350770470511, 00350770470528, 00350770470535, 00350770470542, 00350770470559, 00350770470566, 00350770479521, 00350770479538, 00350770479552, 00350770479576, 00350770479590, 00350770479613, and 00350770479637; 6. 8270-16: 00350770441719, 00350770441726, 00350770441733, 00350770440811, 00350770440828, 00350770440835, 00350770440842, 00350770440859, 00350770440866, 00350770440873, 00350770440880, 00350770440897, 00350770440903, 00350770440910, 00350770440927, 00350770440934, 00350770440941, 00350770440958 ,00350770440965, 00350770440972, 00350770440989, 00350770440996, 00350770441009, 00350770441016 00350770479545, 00350770479569, 00350770479583, 00350770479606, 00350770479620, 00350770479644, and 00350770479736; 7. 8270-18: 00350770441023, 00350770441030, 00350770441054, 00350770441061, 00350770441078, 00350770441085, 00350770441092, 00350770441108, 00350770441115, 00350770441139, 00350770441146, 00350770441153, 00350770441160, 00350770441177, 00350770441184, 00350770441191, 00350770441214, 00350770441221, 00350770441238, 00350770479712, 00350770479699, 00350770479675, 00350770479651, 00350770479668, 00350770479682, and 00350770479705; 8. 8270-22: 00350770441245, 00350770441252, 00350770441269, 00350770441276, 00350770441283, 00350770441290, 00350770441429, 00350770441436, 00350770479729, 00350770479743, 00350770479750, 00350770479767, 00350770479774, 00350770479781, and 00350770479798.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2422-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2422-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-23

Product code KNT

K922667Class IIMic Low Profile Gastrostomy TubeMedical Innovations Corp. / cleared 1993-12-01

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)