Recall Z-1706-2015— Maquet Cardiovascular Us Sales, Llc
Class I · Terminated
Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2015-04-02, terminated 2016-07-06. It names one FDA 510(k) clearance: K133958. Product: FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.. Reason: In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-04-02
- Terminated
- 2016-07-06
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Reason for recall
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.