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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76359

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 25, 2017
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
DeRoyal Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

Z-1247-2017
Recall number
Z-1247-2017
Initiated
January 25, 2017
Classification
Class III
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
849 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

Code information

Lot Numbers: 27453624, 28013145, 28103757, 28117631, 28158774, 28215628, 28230174, 28252349, 28299104, 28317940, 28326230, 28405309, 28455138, 28486735, 28506265, 28568132, 28609969, 28631875, 28736343, 28793541, 28854180, 28908555 28961727, 29015839, 29083612, 29169512, 29214272, 29271744, 29339294, 29412771, 29522363, 29722357, 29754033, 29799485, 29850754, 30021523, 30092305, 30092604, 30134253, 30179216, 30728465, 30819738, 30957330, 31010691, 31015441, 31103782, 31296166, 31402993, 31469522, 31469709, 31576221, 31601554, 31671907, 32333862, 32335500, 32355746, 32550841, 32618796, 32689527, 32728688, 32764718, 32817091, 32834780, 32869000, 32933711, 32980699, 33011814, 33064334, 33087341, 33087350, 33197866, 33682175, 33736364, 33737623, 33783267, 34405461, 34699585, 34762863, 34768309, 34913043, 34939286, 34963841, 35170632, 35270238, 35270529, 35327337, 35544446, 35554708, 35580025, 35598516, 35710820, 35798577, 35828254, 35828449, 35870920, 35898261, 35952677, 36024274, 36081851, 36142094, 36142174, 36200101, 36273801, 36283541, 36309333 36341317, 36530441, 36605837, 36679545, 36953532, 37017210, 37079672, 37079787, 37083356, 37155305, 37189791, 37268916, 37331858, 37395771, 37396029, 37513643, 37654374, 38032551, 38088191, 38180246, 38235278, 38392951, 38457153, 38525030, 38551001, 38623300, 38625866, 38747370, 38788673, 38832507, 38832603, 38997758, 39013351, 39054022, 39076627, 39148951, 39579507, 39661447, 39706174, 39762352, 39812284, 39868780, 40017667, 40080121, 40149328, 40152447, 40264393, 40321968, 40322021, 40342363, 40380888, 40453186, 40453338, 40541549, 40607430, 40890010, 41161601, 41257048, 41263018, 41356935, 41411287, 41467416, 41544848, 41561980, 41601056, 41665404, 41740013, 41755485, 41755506, 42077436, 42077461, 42200721, 42332644, 42332661, 42406164, 42523723, 42523782, 42550246, 43479550, 43493941, 43531688, 43710715

Distribution pattern

MS & LA

device · product 2 of 2

SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

Z-1248-2017
Recall number
Z-1248-2017
Initiated
January 25, 2017
Classification
Class III
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
1157 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.

Code information

Lot Numbers: 27273826, 27324507, 27388691, 27453704, 27567701, 27760202, 27784829, 27883843, 27883851, 27915382, 27970710, 28013209, 28103933, 28117702, 28158889, 28158897, 28373571, 28506329, 28550670, 28678471, 28736415, 28793591, 28854235, 28908619, 28929145, 29015901, 29083680, 29169619, 29206205, 29271816, 29468459, 29522443, 29577604, 29631367, 29694350, 29754130, 29799557, 29850826, 29914025, 29914130, 29963231, 30021654, 30092364, 30092612, 30134245, 30143441, 30253965, 30312507, 30385597, 30487930, 30538274, 30608228, 30608236, 30618098, 30728570, 30776441, 30819771, 30906532, 30957381, 30990041, 31074854, 31155540, 31202772, 31338426, 31469590, 31469717, 31576230, 31671966, 31726138, 31776514, 31776549, 31780847, 31835027, 31886529, 31938886, 31939011, 31990297, 32050811, 32128560, 32133377, 32247761, 32247796, 32302978, 32315875, 32355800, 32421037, 32484206, 32544336, 32550891, 32605910, 32689586, 32764742, 32817154, 32869069, 32933761, 33011857, 33087405, 33217089, 33293188, 33357866, 33425822, 33482579, 33482595, 33539361, 33609787, 33682221, 33736436, 33807644, 33807759, 33876287, 34373462, 34450051, 34518799, 34574037, 34624356, 4699631, 34762927, 34826581, 34856368, 34913078, 34963833, 35033777, 35097560, 35170675, 35230658, 35270297, 35327370, 35400670, 35470555, 35523231, 35544500, 35598559, 35636885, 35638881, 35737011, 35774701, 35798614, 35850620, 35862954, 35877929, 36081869, 36107299, 36142123, 36200119, 36273810, 36282581, 36283559, 36341325, 36399631, 36465555, 36465627, 36548211, 36746488, 36823826, 36888726, 37017295, 37079744, 37155364, 37215937, 37269038, 37269142, 37297899, 37462031, 37513707, 37808046, 37869551, 37931204, 37976189, 38032593, 38088239, 38144000, 38180553, 38235294, 38236166, 38270188, 38270807, 38329400, 38392994, 38393399, 38457217, 38457250, 38573891, 38676461, 38688584, 38688648, 38734991, 38823441, 38898602, 39013335, 39063738, 39076660, 39201803, 39260598, 39303623, 39303631, 39353436, 39413822, 39502403, 39515394, 39559549, 39661519, 39706238, 39762395, 39812313, 39877694, 40272115, 40453207, 40522604, 40754595, 40754608, 40887005, 40888462, 41039809, 41080140, 41080166, 41161581, 41213150, 41279829, 41322330, 41356978, 41411210, 41467459, 41470068, 41544872, 41544901, 41601099, 41669982, 41713883, 41762247, 41830537, 41891081, 41980754, 42026874, 42078789, 42175386, 42240731, 42324142, 42345980, 42346077, 42367054, 42367062, 42368698, 42383628, 42467477, 42561121, 42561156, 42642790, 42679146, 43045591, 43091889, 43127731, 43166001, 43217189, 43454011, 43487584, 43501391, 43542580, 43588166, 43641406, 43742899, 43789030, 43824510, 43875309, 43916895, 43953506, 44039767

Distribution pattern

MS & LA