Perfusion Tubing Pack with BIOLINE Coating (2019-04-03)

Starting date:
April 3, 2019
Posting date:
April 12, 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-69550

Last updated:

Affected Products

Perfusion Tubing Pack with BIOLINE Coating

Reason

Maquet has determined that the sterility assurance level (SAL) requirement of the 3-way stopcock which is included in the HLM Custom Tubing sets cannot be assured in certain lots of the custom tubing sets. A review of all specific HLM Custom Tubing Set design drawings revealed that in various custom tubing sets the  orientation of the 3-way stopcock can restrict air flow into the downstream port of the stopcock. In situations where a non-vented cap is used on the downstream port, the flow of humidity and gas for sterilization can be restricted into the space of the stopcock port. This restriction of flow into the port creates a challenge to the sterilization process for the 3-way stopcock included in the custom tubing set.

Affected products

Perfusion Tubing Pack with BIOLINE Coating

Lot or serial number

92224990
92225321
92228791
92237856
92242678
92243812
92262367

Model or catalog number

BEQ-H 104801
BEQ-H 66603

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