Health product recall

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

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

AVANTI+ CARDIOLOGY SHEATHS

Lot or serial number

17919780
17988227

Model or catalog number

504657A

Companies
Manufacturer

Cordis Corporation

14201 NW 60TH AVE.

MIAMI LAKES

33014

Florida

UNITED STATES