Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1594-2019 | Class II | Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798 | Maquet Cardiovascular LLC | DWF | |
| Z-1593-2019 | Class II | Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797 | Maquet Cardiovascular LLC | DWF | |
| Z-1592-2019 | Class II | Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395 | Maquet Cardiovascular LLC | DWF | |
| Z-1591-2019 | Class II | Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168 | Maquet Cardiovascular LLC | DWF | |
| Z-1590-2019 | Class II | Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008 | Maquet Cardiovascular LLC | DWF | |
| Z-1589-2019 | Class II | Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837 | Maquet Cardiovascular LLC | DWF | |
| Z-1588-2019 | Class II | Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668 | Maquet Cardiovascular LLC | DWF | |
| Z-1587-2019 | Class II | Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577 | Maquet Cardiovascular LLC | DWF | |
| Z-1586-2019 | Class II | Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372 | Maquet Cardiovascular LLC | DWF | |
| Z-1585-2019 | Class II | Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350 | Maquet Cardiovascular LLC | DWF | |
| Z-1584-2019 | Class II | Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280 | Maquet Cardiovascular LLC | DWF | |
| Z-1583-2019 | Class II | Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203 | Maquet Cardiovascular LLC | DWF | |
| Z-1582-2019 | Class II | Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883 | Maquet Cardiovascular LLC | DWF | |
| Z-1581-2019 | Class II | Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664 | Maquet Cardiovascular LLC | DWF | |
| Z-1580-2019 | Class II | Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583 | Maquet Cardiovascular LLC | DWF | |
| Z-1579-2019 | Class II | Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551 | Maquet Cardiovascular LLC | DWF | |
| Z-1578-2019 | Class II | Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366 | Maquet Cardiovascular LLC | DWF | |
| Z-1577-2019 | Class II | Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291 | Maquet Cardiovascular LLC | DWF | |
| Z-1576-2019 | Class II | Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097 | Maquet Cardiovascular LLC | DWF | |
| Z-1575-2019 | Class II | Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823 | Maquet Cardiovascular LLC | DWF | |
| Z-1574-2019 | Class II | Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770 | Maquet Cardiovascular LLC | DWF | |
| Z-1573-2019 | Class II | Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765 | Maquet Cardiovascular LLC | DWF | |
| Z-1492-2019 | Class II | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System... | K2M, Inc | KNW | |
| Z-1491-2019 | Class II | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product... | K2M, Inc | KNW | |
| Z-1572-2019 | Class II | Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620 | Maquet Cardiovascular LLC | DWF | |
| Z-1571-2019 | Class II | Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512 | Maquet Cardiovascular LLC | DWF | |
| Z-1570-2019 | Class II | Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510 | Maquet Cardiovascular LLC | DWF | |
| Z-1569-2019 | Class II | Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504 | Maquet Cardiovascular LLC | DWF | |
| Z-1568-2019 | Class II | Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209 | Maquet Cardiovascular LLC | DWF | |
| Z-1567-2019 | Class II | Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190 | Maquet Cardiovascular LLC | DWF | |
| Z-1566-2019 | Class II | Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992 | Maquet Cardiovascular LLC | DWF | |
| Z-1565-2019 | Class II | Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965 | Maquet Cardiovascular LLC | DWF | |
| Z-1564-2019 | Class II | Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867 | Maquet Cardiovascular LLC | DWF | |
| Z-1563-2019 | Class II | Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834 | Maquet Cardiovascular LLC | DWF | |
| Z-1562-2019 | Class II | Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831 | Maquet Cardiovascular LLC | DWF | |
| Z-1561-2019 | Class II | Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825 | Maquet Cardiovascular LLC | DWF | |
| Z-1560-2019 | Class II | Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804 | Maquet Cardiovascular LLC | DWF | |
| Z-1559-2019 | Class II | Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757 | Maquet Cardiovascular LLC | DWF | |
| Z-1558-2019 | Class II | Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701 | Maquet Cardiovascular LLC | DWF | |
| Z-1557-2019 | Class II | Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590 | Maquet Cardiovascular LLC | DWF | |
| Z-1556-2019 | Class II | Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560 | Maquet Cardiovascular LLC | DWF | |
| Z-1555-2019 | Class II | Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505 | Maquet Cardiovascular LLC | DWF | |
| Z-1554-2019 | Class II | Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255 | Maquet Cardiovascular LLC | DWF | |
| Z-1553-2019 | Class II | Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149 | Maquet Cardiovascular LLC | DWF | |
| Z-1552-2019 | Class II | Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071 | Maquet Cardiovascular LLC | DWF | |
| Z-1551-2019 | Class II | Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899 | Maquet Cardiovascular LLC | DWF | |
| Z-1550-2019 | Class II | Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613 | Maquet Cardiovascular LLC | DWF | |
| Z-1549-2019 | Class II | Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473 | Maquet Cardiovascular LLC | DWF | |
| Z-1548-2019 | Class II | Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310 | Maquet Cardiovascular LLC | DWF | |
| Z-1547-2019 | Class II | Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368 | Maquet Cardiovascular LLC | DWF |