Z-1248-2017 Class III Terminated
FDA device recall Z-1248-2017 was initiated by DeRoyal Industries Inc on January 25, 2017 and is designated Class III. 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, … The recall status is terminated (terminated January 13, 2022). Affected quantity: 1157 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- January 25, 2017
- Termination Date
- January 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1157 units
Product Description
SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
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.
Distribution Pattern
MS & LA
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