Edwards VAMP Jr. blood management system pressure tubing may detach
Edwards Lifesciences is recalling 1,679 units of Edwards VAMP Jr. 6 in blood management systems (lot 63445142, 63630816) due to potential pressure tubing detachment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where tubing detachment could affect patient safety during blood management procedures. No injuries or illnesses have been reported. The FDA Class II classification places this in the High severity category per the rubric.
Plain-English summary
Edwards Lifesciences, LLC is recalling 1,679 units of the Edwards VAMP Jr. 6 in (15 cm) blood management system (REF: VMP306) due to potential detachment of the pressure tubing from the blood sampling system.
The affected units were distributed to healthcare facilities in the United States and internationally to Canada, the United Kingdom, and Italy. The recall affects lot numbers 63445142 and 63630816.
This Class II recall was issued by the FDA due to the risk that the pressure tubing may detach from the blood sampling system, which could compromise the integrity of blood management during surgical procedures.
The recalled product
- Product
- Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 1,679
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 63445142 and 63630816
Distribution
Part of a larger recall action
This product is one of 8 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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