Recall Z-1371-2016— Maquet Cardiovascular Us Sales, Llc
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2016-02-23, terminated 2019-09-25. It names 6 FDA 510(k) clearances: K150267, K102464, K101153 and 3 more. Product: QUADROX-i oxygenators Custom tubing packs for the oxygenator. Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products..
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-23
- Terminated
- 2019-09-25
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
6 on FDA's record- K150267 — QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators
- K102464 — QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
- K101153 — QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
- K093522 — QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
- K090689 — QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
- K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
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 oxygenators Custom tubing packs for the oxygenator
Reason for recall
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
Data sourced from openFDA. This site is unofficial and independent of the FDA.