Fluoroplastic Vent Tube
Brand(s)
Last updated
Summary
Product
Fluoroplastic Vent Tube
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Fluoroplastic Vent Tube |
0231048280 |
1013301 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
| Medtronic Xomed Inc. |
| 6743 Southpoint Drive North, Jacksonville, Florida, United States, 32216 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82740
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