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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