Health product recall

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

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

Affected Products

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

Reason

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.

Affected products

A. Custom Pack with Softline

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

BO-HQV 48412

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

B. Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

BO-VKMO 11000
VKMO 10000
VKMO 11000

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