DeRoyal Heart Tracecart recall
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Why was DeRoyal Heart Tracecart recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 849 units
- Distribution
- MS & LA
- Recall date
- March 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)