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Teflon Tube - Sterile (2013-11-01)
- Starting date:
- November 1, 2013
- Posting date:
- November 29, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36921
Recalled Products
Teflon Tube - Sterile
Reason
Stryker has discovered that there is potential for the product to be non-sterile. It was reported that there was a potential failure during routine maintenance of the sealing machine and it is likely to have caused unsuitable cross seals on the outer pouch. It was reported that there is potential for an unsterile inner pouch of the teflon tube due to missing seal integrity.
Affected products
Teflon Tube - Sterile
Lot or serial number
K0432D3
K057298
K05ECF2
K05ECF3
Model or catalog number
1806-0073S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY