BioComposite SwiveLock (2021-06-08)

Starting date:

June 8, 2021

Posting date:

June 30, 2021

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-75929

Last updated:
2021-06-30

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  Reason
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  Affected products

Affected Products

BioComposite SwiveLock

Reason

All devices in scope were potentially not sealed properly while undergoing the Tyvek header sealing process. As a result, there is a potential that the products in scope were not properly sterilized and presents a risk to health.

Affected products