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LAPSAC AND INTRODUCER (2015-05-28)
- Starting date:
- May 28, 2015
- Posting date:
- June 26, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Identification number:
- RA-53928
Recalled Product
A.LAPSAC
B.LAPSAC INTRODUCER
Reason
Notice advising users of updates to the IFU for the LapSac Surgical Tissue Pouch to remove morcellation from the intended use, warnings and the instructions for use and to add a contraindication. This communication is for informational purposes only and no devices need to be returned. It is intended that all future devices will include the updated IFU. Sales of the device have been suspended until the new IFU can be included with the device.
Affected products
A. LAPSAC
Lot or serial number
All
Model or catalog number
N/A
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES
B. LAPSAC INTRODUCER
Lot or serial number
All
Model or catalog number
N/A
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES