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ALLEN recallZ-2109-2023 · Baxter Healthcare Corporation · initiated May 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2109-2023
Status
Open, Classified
Initiated by the company
May 18, 2023
Posted by the FDA
Jul 7, 2023
Recalling firm
Baxter Healthcare Corporation
Quantity
1,010 units
Product code
GDC
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.

Product description

Allen Advance Chest Support with Pad

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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