Lightweight CABRIO Cable (2021-08-03)

Starting date:

August 3, 2021

Posting date:

September 17, 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-76455

Last updated:
2021-09-17

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  Reason
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  Affected products

Affected Products

Lightweight CABRIO Cable

Reason

A field correction was initiated on august 3, 2021, due to erroneous labeling (i.E. Labels with missing and unintended symbols) that were identified at AD-tech. The field correction is limited to product shipped between july 23, 2021 and july 30, 2021. The unintended symbols on the pouch label may cause confusion about the reuse and re-sterilization of the device, however, the directions for use supplied with the product provide the correct reuse and sterilization information. The missing symbols on the pouch label are required for conformity to EU MDR (2017/745), but are not required in the United States or Canada. Zero potential serious injuries have been reported to AD-tech medical instrument corporation relating to this erroneous label at the time of this field correction.

Affected products