Health product recall

Perfusion Pack, Custom Pack with SOFTLINE, Perfusion Set (with SOFTLINE, BIOLINE Coating) (2019-02-19)

Starting date:
February 19, 2019
Posting date:
March 15, 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-69324

Affected Products

  1. Perfusion Pack
  2. Custom Pack with SOFTLINE
  3. Perfusion set with SOFTLINE Coating
  4. Perfusion Set with BIOLINE Coating

Reason

Maquet Cardiopulmonary has been informed that the printed information on the front and back side of the pre-bypass filter, showed incomplete print quality. Internal investigations have revealed that the print on the filters had already been partially removed out of the packaging or it was also detected that the printing could be removed by touching with hands. The print does not necessarily come off during transport. Even if the print is still fully intact it could be an affected device. The print may be removed when touched without any solvent used.

Affected products

A. Perfusion Pack

Lot or serial number
  • 92266985
  • 92267058
Model or catalog number

HQV 94500

Companies
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY

B. Custom Pack with SOFTLINE

Lot or serial number

92246216

Model or catalog number

BO-HQV 55004

Companies
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY

C. Perfusion set with SOFTLINE Coating

Lot or serial number

92247616

Model or catalog number

BO-HQV 46904

Companies
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY

D. Perfusion Set with BIOLINE Coating

Lot or serial number

92267194

Model or catalog number

BEQ-HQV 46904

Companies
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY