Product Wiki · Recalls · Health Canada — Medical Devices

Perfusion Tubing Pack with BIOLINE Coating (2019-04-03) — recall 59330

Health Canada — Medical Devices · Canada · 2019-04-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59330
Date of alert
2019-04-12
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/perfusion-tubing-pack-bioline-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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