Maquet Cardiovascular, LLC Recall: Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504
Maquet Cardiovascular, LLC Recall: Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Maquet Cardiovascular, LLC; Product: Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Ad
| Recalling firm | Maquet Cardiovascular, LLC |
|---|---|
| Product | Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack |
| Reason for recall | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide |
| Recall initiated | 20190418 |
| Recall number | Z-1663-2019 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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