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Maquet Cardiovascular, LLC Recall: Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 70

Maquet Cardiovascular, LLC Recall: Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 70 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Maquet Cardiovascular, LLC; Product: Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754; Reason for recall: Custom Tubing Sets for Extr

Recalling firmMaquet Cardiovascular, LLC
ProductMaquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754
Reason for recallCustom 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide
Recall initiated20190418
Recall numberZ-1528-2019
Categorydevice
StateNJ
CountryUnited States

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