This page has been archived on the Web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.
Stryker Smartlife - Small and Large Aseptic Housing (2014-09-30)
- Starting date:
- September 30, 2014
- Posting date:
- October 9, 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-41693
Recalled Products
A) Stryker Smartlife - Small Aseptic Housing
B) Stryker Smartlife – Large Aseptic Housing
Reason
Stryker has become aware that periodic testing, normally completed during the manufacturing process, was not conducted for products manufactured between March 28, 2014 and May 2, 2014. Changes to the quality of the weld during this period may not have been detected and may be less effective than intended.
Affected products
A) Stryker Smartlife - Small Aseptic Housing
Lot or serial number
13027 to 14093
Model or catalog number
7222-120-000
Companies
- Manufacturer
-
Stryker Instruments
4100 East Milham Ave.
Kalamazoo
49001
Michigan
UNITED STATES
B) Stryker Smartlife – Large Aseptic Housing
Lot or serial number
13027 to 14093
Model or catalog number
7126-120-000
Companies
- Manufacturer
-
Stryker Instruments
4100 East Milham Ave.
Kalamazoo
49001
Michigan
UNITED STATES