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MEDPOR Sizer Sets and TLS Surgical Drainage System (2016-12-28)
- Starting date:
- December 28, 2016
- 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-61846
Affected Products
- MEDPOR Sizer Sets
- TLS Surgical Drainage System - Quintube Monitor Pack
Reason
Stryker received a report indicating that the outer label of a MEDPOR Sizer Set states 'sterile', whereas the product is actually delivered non-sterile. Investigations revealed that additional products and lots have an incorrect sterility status on their labels.
Affected products
A. MEDPOR Sizer Sets
Lot or serial number
- M1305001
- M1603003
Model or catalog number
- 85000
- 9951
Companies
- Manufacturer
-
Stryker Leibinger GmbH and Co. KG
Botzinger Strasse 41
Freiburg
79111
GERMANY
B. TLS Surgical Drainage System - Quintube Monitor Pack
Lot or serial number
- M1309004
- M1309007
Model or catalog number
- 6630
Companies
- Manufacturer
-
Stryker Leibinger GmbH and Co. KG
Botzinger Strasse 41
Freiburg
79111
GERMANY