FDA Device

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

Hazard

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.

What You Should Do

Remedy

DeRoyal issued their recall on 01/25/17 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors and hospitals were instructed to return the tracecarts to DeRoyal.

Products

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

Units Affected

849 units