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
Reported: July 7, 2021 Initiated: May 26, 2021 #Z-1961-2021
Product Description
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
Reason for Recall
There is a potential that the pressure tubing may detach from the blood sampling system
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 290 units
- Distribution
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Edwards Lifesciences, LLC. Units affected: 290 units.
Why was this product recalled? ▼
There is a potential that the pressure tubing may detach from the blood sampling system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1961-2021.
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