F-Decalin, F-Octane (2019-04-11)

Starting date:

April 11, 2019

Posting date:

May 3, 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-69826

Last updated: 2019-05-03

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  Reason
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  Affected products

Affected Products

A. F-Decalin

B. F-Octane

Reason

The recall is being initiated because the secondary packaging might be perforated by an irregularity in the syringe baking stop variant used.  This can impair the sterility of the primary packaging; the sterility of the syringe content remains guaranteed. No injuries or damage have been reported in connection with this issue.

Affected products