Sterile Lap Chole Pack, Gyne Laparoscopy Pack (2019-04-01)
- Starting date:
- April 1, 2019
- Posting date:
- April 12, 2019
- 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-69572
Last updated: 2019-04-12
Affected Products
- Sterile Lap Chole Pack
- Gyne Laparoscopy Pack
Reason
This voluntary recall is being conducted in response to a field corrective action from Stryker, where there is a risk of the tubing detaching from the cassette in their PneumoSure tubesets. This could result in a lack of inflation making it difficult to visualize surgical locations during procedures. The affected surgical kits from Cardinal Presource contain one of the affected Stryker tubesets in their components.
Affected products
-
Sterile Lap Chole Pack
Lot or serial number
113569
701169
707623
750706
798417
804663
925028
Model or catalog number
SBA30LCCWB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
B. Gyne Laparoscopy Pack
Lot or serial number
106541
199463
715771
769311
788313
896702
925462
Model or catalog number
SLC30GLCW1
SLC30GLCWD
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES