FDAClass IIJuly 19, 2023

Allen Advance Chest Support with Pad recall

Allen Advance Chest Support with Pad

Why was Allen Advance Chest Support with Pad recalled?

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product code A-71301; GTIN Number: (01)00615521003159; a. Lot Codes: 19-238, 19-238, 19-287, 19-337, 19-337, 19-352, 20-225, 21-085, 21-102, 21-102, 20-326, 19-170, 19-170, 19-150, 19-150, 19-162, 19-326, 20-031, 20-072, 20-245, 19-235, 20-091, 21-057, 19-352, 20-031, 20-044, 20-063, 20-245, 20-245, 20-259, 20-259, 21-109, 21-109, 20-064, 20-225, 21-014, 19-190, 19-326, 20-014, 20-014, 20-063, 20-259, 20-259, 21-085, 21-048, 19-287, 20-072, 19-295, 19-302, 21-085, 19-134, 19-179, 19-179, 19-235, 19-235, 20-014, 20-326, 20-343, 21-085, 19-150, 21-014, 20-357, 20-009, 20-042, 20-064, 21-109, 19-287, 19-287, 19-287, 19-288, 20-031, 20-043, 20-043, 20-063, 20-091, 20-225, 20-309, 20-318, 21-036, 21-036, 21-036, 21-036, 19-141, 19-150, 19-150, 19-150, 19-150, 19-162, 19-162, 19-150, 19-150, 19-157, 19-157, 19-161, 19-161, 19-179, 19-190, 19-190, 19-190, 19-190, 19-161, 19-190, 19-179, 19-179, 19-238, 19-238, 19-238, 19-238, 19-238, 19-235, 19-179, 19-179, 19-235, 19-235, 19-235, 19-179, 19-295, 19-295, 19-287, 19-287, 19-287, 19-344, 19-302, 19-344, 19-344, 19-302, 19-287, 19-179, 20-009, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 19-288, 20-043, 20-035, 19-352, 20-044, 20-042, 20-064, 20-031, 20-063, 20-044, 20-014, 20-031, 20-042, 20-042, 20-042, 20-042, 20-225, 20-223, 20-245, 20-245, 20-245, 20-240, 20-259, 20-259, 20-318, 20-318, 20-259, 20-318, 20-326, 20-326, 20-309, 20-343, 20-357, 21-005, 21-005, 20-357, 21-005, 21-005, 21-014, 21-014, 20-357, 21-048, 21-048, 21-048, 21-057, 21-057, 21-057, 21-079, 21-079, 21-079, 21-109, 21-109, 21-109, 21-109, 21-109, 20-073, 21-102, 21-102, 19-219, 20-245, 20-290, 19-141, 19-141, 19-150, 19-150, 19-190, 19-235, 20-031, 20-042, 20-091, 20-245, 20-245, 19-141, 19-150, 19-157, 19-190, 19-190, 19-235, 19-235, 19-238, 19-238, 19-238, 19-287, 19-288, 19-295, 19-326, 20-009, 20-042, 20-063, 20-063, 20-072, 20-223, 20-223, 20-240, 20-240, 20-042, 20-309, 21-048; b. Serial Numbers: A310704, A357947, A360200, A365287, A375034, A375035, A375036, A416606, A420046, A448084, A452816, A471811, A277527, A277528, A279563, A279562, A277446, A277526, A282019, A282021, A282023, 429589, A282815, A283349, A282814, A282816, A283901, A283902, A283905, A283348, A284963, A285887, A285889, A285891, A284961, A284303, A284304, A284298, A286694, A285890, A291760, A287624, A285888, A287623, A292761, A292758, A292754, A292764, A287622, A294806, A294807, A292757, A292756, A294805, A297712, A296452, A297713, A294803, A300078, A300079, A294810, A302576, A304247, A304248, A304246, A305685, A305686, A294804, A305290, A305289, A305688, A306433, A306706, A306705, A306704, A306434, A308755, A308756, A305287, A305288, A310148, A310702, A310149, A310703, A306436, A308184, A313214, 395159, A314036, A313215, A315373, A310150, A315374, A315375, A306435, A309415, A308757, A314482, A314483, A315892, A315893, A317667, A317666, A309416, A316612, A316613, A315891, A314481, A315894, A315895, A316614, A317668, A318948, A318949, A318064, A318950, A318065, A318066, A319766, A319767, A321937, A319765, A321938, A321936, A320448, A322426, A322427, A320852, A324672, A324670, A325034, A324673, A325038, A325035, A325037, A327579, A326495, A327581, A326497, A328335, A324674, A328699, A328332, A328334, A328333, A328336, A326496, A328697, A330272, A330273, A330275, A326499, A329153, A329154, A329152, A326498, A330274, A328700, A328696, A329155, A333390, A333393, A334200, A334199, A334197, A337070, A334201, A337541, A335292, A337071, A337072, A338188, A338190, A335293, A337073, A339467, A338187, A338186, A339468, A339469, A339471, A340661, A340663, A340662, A340659, A337542, A342758, A342299, A342761, A342762, A342300, A343762, A342760, A343760, A343180, A343182, A342301, A342759, A335294, A335295, A346956, A343179, A348719, A347562, A343181, A349179, A349178, A349176, A349925, A349923, A349924, A349926, A337074, A349180, A349927, A348717, A346958, A348718, A349177, A346954, A353968, A353967, A346957, A356578, A356575, A355198, A356577, A357943, A358744, A357946, A358747, A360196, A360198, A356576, A355196, A355197, A356574, A361153, A363379, A363380, A365290, A365288, A361155, A364647, A364650, A364648, A361154, A361157, A366894, A366897, A361156, A366895, A369285, A371200, A371833, A371831, A370964, A370968, A373009, A373007, A373010, A373011, A371201, A371204, A370966, A375500, A375501, A373974, A373975, A373976, A378135, A378136, A370967, A375037, A376988, A380128, A380127, A376986, A376987, A380126, A380129, A381012, A381013, A381009, A375502, A384933, A347558, A347559, A386376, A376984, A376985, A384937, A388848, A387925, A387923, A385776, A385779, A385780, A387924, A391327, A391328, A388847, A391324, A385777, A387406, A387410, A387408, A387407, A396340, A396341, A395917, A395918, A395919, A395920, A397230, A391326, A397234, A397232, A347561, A393696, A393693, A387409, A393694, A393695, A392498, A397233, A320447, A401570, A392500, A401574, A393697, A402910, A402911, A404480, A388846, A405307, A406883, A406887, A405305, A408249, A406885, A408246, A408247, A408248, A406884, A409140, A404484, A409142, A410098, A410096, A410099, A410095, A412218, A412222, A389898, A412220, A412219, A411532, A413045, A413049, A413047, A413048, A413747, A413748, A411531, A416604, A416607, A415777, A415776, A286693, A415775, A417502, A417504, A418527, A420049, A420047, A417501, A420045, A420048, A417503, A418529, A392497, A422259, A422260, A422254, A422255, A422261, A422258, A423366, A423365, A423362, A423363, A422256, A422262, A425350, A425349, A425849, A425848, A425355, A425850, A428078, A426843, A428079, A422253, A426847, A425354, A428081, A428082, A430036, A430626, A430035, A423364, A425348, A425847, A430889, A432302, A431880, A432304, A430888, A434264, A434263, A434546, A434548, A434549, A435902, A435900, A435903, A366893, A436095, A436092, A436091, A435899, A435901, A434550, A441729, A441732, A441730, A442316, A442317, A442318, A444339, A444338, A444336, A444598, A444599, A444600, A445304, A445303, A444601, A445305, A446058, A446059, A447482, A447483, A447479, A447480, A448082, A448083, A449263, A447481, A449264, A449265, A449262, A445302, A451721, A451722, A451723, A452815, A453772, A453771, A454423, A456229, A456228, A456864, A457580, A456863, A378138, A456375, A456376, A458653, A458655, A459953, A460528, A459954, A460996, A460998, A460530, A460531, A461945, A463227, A463228, A464880, A464881, A464882, A464883, A465576, A465575, A465577, A466360, A459955, A468113, A470003, A470002, A468114, A470561, A470562, A471812, A471813, A472122, A472123, A472124, A472125, A472545, A472544, A472543, A473809, A473808, A473810, A476032, A476033, A475324, A463856, A473811, A478212, A478210, A478211, A478209, A395921, A480983, A480984, A480985, A481073, A481076, A481074, A481075, A481402, A323844, A323845, A365289, A380125, A456374, A475322, A282020, A292755, A286696, A337540, A342302, A343761, A353969, A353970, A358745, A378137, A401572, A412221, A416603, A425352, A425846, A449656, A458172, A284301, A415774, A456230, A411534, A430890, A282813, A346955, A384934, A384935, A384936, A389896, A402908, A402912, A404483, A417505, A418526, A422257, A430627, A458171, A460999, A468106, A468107, A468108, A468109, A468110, A313213, A327578, A330276, A475323, A342303, A369287, A432303, A276164, A276165, A279560, A279565, A283900, A283903, A283904, A284296, A286695, A296451, A302574, A302575, A308185, A309417, A320853, A320854, A333391, A333392, A340660, A355200, A357944, A357945, A358746, A360199, A363381, A364649, A366896, A369283, A369284, A369286, A371829, A371830, A370965, A373008, A375503, A373977, A381010, A381011, A386378, A386379, A388845, A389895, A389897, A392499, A392501, A401573, A404482, A406886, A410097, A411533, A413744, A413745, A413746, A415778, A426845, A426846, A428080, A430034, A431879, A434262, A436093, A441731, A442801, A442802, A444337, A446056, A446057, A449654, A451724, A452813, A452814, A461648, A461649, A461650, A461946, A461947, A461948, A468112, A470001, A473031, A473032, A476030, A476031, A480986, A480987, A396338, A472546, A360197, A300077, A328698, A348721, A426844, A347560, A386377, A468111, A364651, A459956, A305687, A348720, A425353, A425356, A408245, A334198, A375504, A387922, A431881, A409143, A338189, A308186, A294802, A297016, A396339, A396342, A292762, A339470, A416605, A418525, A297711, A320446, A355199, A389894, A442799, A442800, A442315, A276166, A284302, A365286, A449657, A473033, A473034, A281813, A284299, A314035, A323126, A323127, A323128, A322428, A323846, A323847, A323848, A323849, A324669, A324671, A325033, A325036, A327117, A327118, A327119, A327120, A327121, A326500, A337543, A358748, A387921, A454422, A457581, A458652, A463857, A281814, A314037, A329151, A335291, A337539, A343758, A343759, A371832, A371202, A375033, A402909, A404481, A409141, A425347, A425351, A430628, A436094, A458654, A460529, A460997, A461651, A475321, A294809, A305684, A471814, A481403, A481404, A481405

Product
Allen Advance Chest Support with Pad
Recalling firm
Baxter Healthcare Corporation
Quantity
1,010 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Recall date
July 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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