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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