AVANTI+ CARDIOLOGY SHEATHS (2021-06-09)

Starting date:

June 9, 2021

Posting date:

June 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-75823

Last updated:
2021-06-17

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  Reason
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  Affected products

Affected Products 

AVANTI+ CARDIOLOGY SHEATHS

Reason

Cordis became aware that the catalog 504-657A, size 7F MS (approximately 7.5F) is mislabeled (both outer and inner labels) as size 7F because of a missing "Mid Size" ("MS") designation. The product in the mislabeled packaging is larger (both inner and outer diameter) than the labeling indicates. The difference (0.5F) represents approximately 0.006 inches.

Affected products