FDAFDA · Food and drugs·Recall number Z-1961-2021
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Published July 7, 2021 · Recall initiated: May 26, 2021
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
There is a potential that the pressure tubing may detach from the blood sampling system
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
- Lot
- Lot # 63479666- Not Marketed within the US
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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