Avanos Medical, Inc. Recall 94385
Description: 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).
Avanos Medical, Inc. Recall 94385 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2422-2024 |
| Event ID | 94385 |
| Event Description | 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 Type | Devices |
| Distribution | Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia. |
| Quantity | 53,384 kits |
| Recall Reason | The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications. |
| Device Classification | 20240731 |
| Device Code Info | 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. |
| Center Classification Date | 20240723 |
| Recall Initiation Date | 20240531 |
| Recalling Firm | Avanos Medical, Inc. |
| Initial Notification | Letter |
| Similar To |