—#200570

Product

Allen Advance Chest Support with Pad

FDA product code: GDC — Table, Operating-Room, Electrical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Baxter Healthcare notified customers, via USPS letter, on 05/18/2023. Customers were instructed to 1. Identify affected product and discontinue use of the old design until a replacement unit is provided. 2. Contact Baxter Order Management team to arrange the return and replacement of affected devices. 3. Acknowledge receipt of this letter by completing a reply form on the customer portal, even if there is no inventory on hand, if received directly from Baxter. 4. Please return the acknowledgement form to your distributor/wholesaler according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers and check the associated box on the customer portal reply form. Baxter initiated an expansion for additional impacted units and consignees An updated customer notification was sent to all affected customers on 06/12/2023.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-05-18
Posted by FDA: 2023-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #200570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.