Recall Monitor
Health Products

Fluoroplastic Vent Tube

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ear, nose and throat
Product: Fluoroplastic Vent Tube
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Fluoroplastic Vent Tube02310482801013301

Issue

Vent tube devices across lot 0231048280 were identified to have been released to customers without undergoing sterilization. the issue is currently understood to originate from manufacturing (load preparation) and represents a fault condition: the product does not meet its specification for sterility (SAL 10-6) or its labeled sterile state.

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