The Recall Desk
HighFDA (Devices)·Z-1963-2021·Announced 2021-07-07

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.

What this means for you

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
Category
Medical Device — Cardiac Surgery / Blood Management
Hazard
  • tubing-detachment
  • equipment-failure

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

Distributed in 33 states:

  • 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

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