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Custom Sterile General Gyne Pack and General Gyneco Laparoscopie (August 06, 2013)
- Starting date:
- August 06, 2013
- Posting date:
- August 06, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35411
Reason
Deroyal is conducting a voluntary recall of specific lots of insufflation tubing sets which are components found in the presource kits mentioned above. The reason for the recall is due to a materials incompatibility which could possibly result in occlusion at or near the filter housing. The occlusion could prevent the flow of gas through the device.
Affected products
A. Custom Sterile General Gyne Pack
Lot or serial number
116777, 129540, 139274, 148534, 151601, 161836, 76132, 92006, 99852
Model or catalog number
SMA30GEGMD
Companies
- Manufacturer
- Not Applicable
B. General Gyneco Laparoscopie
Lot or serial number
106305, 114716, 119591, 125979, 131069, 146261, 157700, 166248
Model or catalog number
SMA30LGGMC
Companies
- Manufacturer
- Not Applicable
- Date modified: