FDA Device recall Z-2422-2024
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT)
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT) by Avanos Medical, citing the IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2422-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-31 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avanos Medical |
| Distribution | US |
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).
Reason
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Identifiers
| code_info | All lot numbers. UDI-DI numbers: 1. 0270-14: 00350770472171, 00350770472188, 00350770472195, 00350770472201, 003507…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2422-2024%22
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