MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube...
FDA Recall #Z-2422-2024 — Class II — May 31, 2024
Product 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).
Reason for Recall
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Recalling Firm
Avanos Medical, Inc. — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
53,384 kits
Distribution
Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated