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Cordis Exoseal Vascular Closure Device
- Starting date:
- October 31, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15893
Recalled Products
A. Cordis Exoseal Vascular Closure Device
Reason
Cordis has identified a potential issue where the affected lots (all lot numbers from 15466779 to 15682751) of Cordis Exoseal VCD have been sterilized using a process that did not achieve the sterlility assurance level that is required by the standards for this class of product.
Affected products
A. Cordis Exoseal Vascular Closure Device
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
EX500CE, EX600CE, EX700CE
Companies
- Manufacturer
- Zimmer Inc.