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Saber Bulb KIT (2014-03-20)
- Starting date:
- March 20, 2014
- Posting date:
- June 5, 2014
- 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-39859
Recalled Products
Saber Bulb KIT (2014-03-20)
Reason
The failures during this testing for EO cycle 680 indicate that the sterile barrier may be compromised in this product family.
Affected products
Saber Bulb KIT (2014-03-20)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
310019
Companies
- Manufacturer
-
Aspen Surgical Products, Inc.
6945 Southbelt Drive, SE
Caledonia
49316
Michigan
UNITED STATES