Recall Z-0436-2019— Maquet Cardiovascular Us Sales, Llc
Class I · Terminated
Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2018-10-25, terminated 2020-06-05. It names 2 FDA 510(k) clearances: K141432, K102464. Product: QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.. Reason: There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-10-25
- Terminated
- 2020-06-05
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
- K102464 — QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
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
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Reason for recall
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.