Recall Z-1959-2021— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2021-05-26, terminated 2023-12-14. It names 2 FDA 510(k) clearances: K161962, K142749. 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. Reason: There is a potential that the pressure tubing may detach from the blood sampling system.
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-26
- Terminated
- 2023-12-14
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K161962 — VAMP Venous/Arterial Blood Management Protection System
- K142749 — TruWave Disposable Pressure Transducer
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
There is a potential that the pressure tubing may detach from the blood sampling system
Data sourced from openFDA. This site is unofficial and independent of the FDA.