Custom Pack with Softline, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir (2019-05-12)

Custom Pack with Softline, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir (2019-05-12) - Recalls and safety alerts
Starting date:
May 12, 2019
Posting date:
May 24, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70023

Last updated:

2019-05-24
  1. Custom Pack with Softline
  2. Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir

Maquet Cardiopulmonary has received complaints in relation to leakage at the QUADROX-i Neonatal blood inlet connector.
Internal investigations have revealed that the leakage only occurs if the enclosed reducing screw adapter 1/4"" x 3/16"" is screwed onto the blood inlet connector of the QUADROX-i Neonatal Oxygenator. The leakage occurs due to a non-conforming blood inlet connector that, in conjunction with the use of the screw reducing adapter 1/4"" x 3/16"", does not result in a tight connectoradapter connection. The combination of the reducing screw adapter 1/4"" x 3/16"" with the blood outlet connector or the use of the blood inlet connector directly to tubing does not exhibit any leakage.

 

More than 10 numbers, contact manufacturer.

BO-HQV 48412

Manufacturer
MAQUET CARDIOPULMONARY GMBH KEHLER STR. 31, RASTATT, GERMANY, 76437 RASTATT 76437 GERMANY

 

 

 

More than 10 numbers, contact manufacturer.

BO-VKMO 11000
VKMO 10000
VKMO 11000

Manufacturer
MAQUET CARDIOPULMONARY GMBH KEHLER STR. 31, RASTATT, GERMANY, 76437 RASTATT 76437 GERMANY

Did you like this article?