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AMS Advance SP Male Sling System (2014-07-28)
- Starting date:
- July 28, 2014
- Posting date:
- October 29, 2014
- 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-41937
Recalled Products
AMS Advance SP Male Sling System
Reason
3 year real time aging samples for Monarc+ needle passers were found to have breach and seal width failures upon testing.
Affected products
AMS Advance SP Male Sling System
Lot or serial number
Comp.affected 200517-01
Model or catalog number
720163-01
Companies
- Manufacturer
-
American Medical Systems Inc.
10700 Bren Road West
Minnetonka
55343
Minnesota
UNITED STATES