This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Diego Elite Tubeset (2015-05-04)
- Starting date:
- May 4, 2015
- Posting date:
- May 26, 2015
- 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-53509
Recalled Products
A. Diego Elite Tubeset
Reason
Manufacturer has identified compromises in sterile packaging that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may not be easily seen. Manufacturer has not received any complaints of injury associated with compromised sterile packaging. However, it is possible that use of non-sterile product may introduce microbes and increase the potential for postoperative infection.
Affected products
A. Diego Elite Tubeset
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- TS100S
- TS101DC
Companies
- Manufacturer
-
Gyrus Acmi
Inc.
136 Turnpike Road
Massachusetts
UNITED STATES