FDAFDA · Food and drugs·Recall number Z-1662-2019
Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
Published June 5, 2019 · Recall initiated: April 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- Nationwide
- Lot
- Batch Numbers: 3000060743 3000066277 3000069078 3000073171 3000074176 3000076468 3000080999 3000081905 3000085277
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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