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: 2019-04-12

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  Reason
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  Affected products

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