Reported Jul 31, 2024 · Ongoing

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

Avanos Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894

Is this the product you have?

8 of 8 products

Products covered by this recall
#	Product as published
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).

Lot codes and dates: 8 of 8 products
Products covered by this recall
# Barcodes Product as published
1 0035077047217100350770472188003507704721950035077047220100350770472225003507704722320035077047224900350770472256003507704722630035077047227000350770472287003507704722940035077047230000350770472317003507704723310035077047234800350770472355003507704723620035077047237900350770472386003507704723930035077047240900350770472423003507704724160035077047923100350770479279003507704792620035077047925500350770479293 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 0035077095491200350770954929003507709549360035077095494300350770954950003507709549670035077095497400350770954981003507709549980035077095635000350770956367003507709563740035077095638100350770956398003507709564040035077095641100350770956428003507709564350035077095644200350770956459003507709564660035077095647300350770956480003507709564970035077047930900350770479316003507704793230035077047938500350770479354 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 0035077095650300350770956510003507709565270035077095653400350770956541003507709565580035077095656500350770956572003507709565890035077095659600350770956602003507709566190035077095662600350770956633003507709566400035077095665700350770956664003507709566710035077095668800350770479347003507704793300035077047939200350770479408003507704794150035077047942200350770479439 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 003507709566950035077095670100350770956718003507709567250035077095673200350770956749003507709567560035077095676300350770479446003507704794530035077047946000350770479477003507704794840035077047949100350770479514 0270-22: 00350770956695, 00350770956701, 00350770956718, 00350770956725, 00350770956732, 00350770956749, 00350770956756, 00350770956763, 00350770479446, 00350770479453, 00350770479460, 00350770479477, 00350770479484, and 00350770479491, 00350770479514
5 00350770470207003507704702380035077047024500350770470320003507704703510035077047036800350770470375003507704703820035077047039900350770470405003507704704120035077047042900350770470436003507704704500035077047046700350770470474003507704704810035077047049800350770470511003507704705280035077047053500350770470542003507704705590035077047056600350770479521003507704795380035077047955200350770479576003507704795900035077047961300350770479637 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 00350770441719003507704417260035077044173300350770440811003507704408280035077044083500350770440842003507704408590035077044086600350770440873003507704408800035077044089700350770440903003507704409100035077044092700350770440934003507704409410035077044095800350770440965003507704409720035077044098900350770440996003507704410090035077044101600350770479545003507704795690035077047958300350770479606003507704796200035077047964400350770479736 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 0035077044102300350770441030003507704410540035077044106100350770441078003507704410850035077044109200350770441108003507704411150035077044113900350770441146003507704411530035077044116000350770441177003507704411840035077044119100350770441214003507704412210035077044123800350770479712003507704796990035077047967500350770479651003507704796680035077047968200350770479705 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 003507704412450035077044125200350770441269003507704412760035077044128300350770441290003507704414290035077044143600350770479729003507704797430035077047975000350770479767003507704797740035077047978100350770479798 8270-22: 00350770441245, 00350770441252, 00350770441269, 00350770441276, 00350770441283, 00350770441290, 00350770441429, 00350770441436, 00350770479729, 00350770479743, 00350770479750, 00350770479767, 00350770479774, 00350770479781, and 00350770479798.
Amount recalled: 53,384 kits

Where it was sold

Nationwide

Why it was recalled

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Avanos Medical, Inc.

19 in total.

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#	Barcodes	Product as published
1	`0035077047217100350770472188003507704721950035077047220100350770472225003507704722320035077047224900350770472256003507704722630035077047227000350770472287003507704722940035077047230000350770472317003507704723310035077047234800350770472355003507704723620035077047237900350770472386003507704723930035077047240900350770472423003507704724160035077047923100350770479279003507704792620035077047925500350770479293`	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	`0035077095491200350770954929003507709549360035077095494300350770954950003507709549670035077095497400350770954981003507709549980035077095635000350770956367003507709563740035077095638100350770956398003507709564040035077095641100350770956428003507709564350035077095644200350770956459003507709564660035077095647300350770956480003507709564970035077047930900350770479316003507704793230035077047938500350770479354`	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	`0035077095650300350770956510003507709565270035077095653400350770956541003507709565580035077095656500350770956572003507709565890035077095659600350770956602003507709566190035077095662600350770956633003507709566400035077095665700350770956664003507709566710035077095668800350770479347003507704793300035077047939200350770479408003507704794150035077047942200350770479439`	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	`003507709566950035077095670100350770956718003507709567250035077095673200350770956749003507709567560035077095676300350770479446003507704794530035077047946000350770479477003507704794840035077047949100350770479514`	0270-22: 00350770956695, 00350770956701, 00350770956718, 00350770956725, 00350770956732, 00350770956749, 00350770956756, 00350770956763, 00350770479446, 00350770479453, 00350770479460, 00350770479477, 00350770479484, and 00350770479491, 00350770479514
5	`00350770470207003507704702380035077047024500350770470320003507704703510035077047036800350770470375003507704703820035077047039900350770470405003507704704120035077047042900350770470436003507704704500035077047046700350770470474003507704704810035077047049800350770470511003507704705280035077047053500350770470542003507704705590035077047056600350770479521003507704795380035077047955200350770479576003507704795900035077047961300350770479637`	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	`00350770441719003507704417260035077044173300350770440811003507704408280035077044083500350770440842003507704408590035077044086600350770440873003507704408800035077044089700350770440903003507704409100035077044092700350770440934003507704409410035077044095800350770440965003507704409720035077044098900350770440996003507704410090035077044101600350770479545003507704795690035077047958300350770479606003507704796200035077047964400350770479736`	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	`0035077044102300350770441030003507704410540035077044106100350770441078003507704410850035077044109200350770441108003507704411150035077044113900350770441146003507704411530035077044116000350770441177003507704411840035077044119100350770441214003507704412210035077044123800350770479712003507704796990035077047967500350770479651003507704796680035077047968200350770479705`	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	`003507704412450035077044125200350770441269003507704412760035077044128300350770441290003507704414290035077044143600350770479729003507704797430035077047975000350770479767003507704797740035077047978100350770479798`	8270-22: 00350770441245, 00350770441252, 00350770441269, 00350770441276, 00350770441283, 00350770441290, 00350770441429, 00350770441436, 00350770479729, 00350770479743, 00350770479750, 00350770479767, 00350770479774, 00350770479781, and 00350770479798.