Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment
Edwards Lifesciences is recalling its pressure monitoring set due to potential tubing detachment. Approximately 460 units distributed across North America and Europe are affected.
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: FDA Class II recall with no reported illnesses or injuries. The potential tubing detachment represents a risk of harm to patients during critical pressure monitoring, but no harm has been confirmed yet. This meets the criteria for High severity: risk-of-harm product without reported injury.
Plain-English summary
Edwards Lifesciences is recalling the Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, a pressure monitoring set used in medical settings. The recalled units are identified by Reference Number PXVJ356, with Lot Numbers 63505216 and 63590087.
The recall is being issued because there is a potential that the pressure tubing may detach from the blood sampling system. This could affect the ability to accurately monitor blood pressure during critical patient care.
Approximately 460 units were distributed across the United States (including 32 states and Puerto Rico), Canada, the United Kingdom, and Italy.
Healthcare providers who have this product should review the recall notice and take appropriate action as directed by Edwards Lifesciences and their regulatory authorities.
The recalled product
- Product
- Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
- Manufacturer
- Edwards Lifesciences, LLC
- 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 #s: 63505216 and 63590087
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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