Recall Z-1386-2019— Vyaire Medical
Class I · Terminated
Class I FDA medical device recall by Vyaire Medical, initiated 2019-03-13, terminated 2020-09-22. It names 2 FDA 510(k) clearances: K130867, K060537. Product: enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.. Reason: Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-03-13
- Terminated
- 2020-09-22
- Firm location
- Mettawa, IL, United States
510(k) clearances named in this recall
2 on FDA's record- K130867 — ENFLOW IV FLUID WARMER INSULATED STRAP
- K060537 — EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
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
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Reason for recall
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Data sourced from openFDA. This site is unofficial and independent of the FDA.