Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Reported: July 7, 2021 Initiated: May 26, 2021 #Z-1963-2021
Product Description
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
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
- 1,679 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 VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782. Recalled by Edwards Lifesciences, LLC. Units affected: 1,679 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-1963-2021.
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