Z-2109-2023Class II

Allen Advance Chest Support with Pad

Name: Z-2109-2023 Allen Advance Chest Support with Pad
Creator: Baxter Healthcare Corporation
Published: 2023-05-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-05-18 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Allen Advance Chest Support with Pad on 2023-05-18. FDA classified it as Class II and gives the reason as "Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2109-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-07-07
Recalling firm: Baxter Healthcare Corporation
Product: Allen Advance Chest Support with Pad
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2109-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2109-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-19	2023-07-07

Product code GDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)