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700 CX/ CXM Inflatable Penile Prosthesis (2014-10-22)
- Starting date:
- October 22, 2014
- Posting date:
- November 7, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42067
Recalled Products
700 CX/ CXM Inflatable Penile Prosthesis
Reason
Lightning bolt Keith needle assembly may have needles found in 3 lots that appear to be missing a bend near the eyelet which may lead to an increased rate of bent or broken needles. These are found in AMS 700 series inflatable penile prosthesis accessory kit.
Affected products
700 CX/ CXM Inflatable Penile Prosthesis
Lot or serial number
865869024
884422015
884422018
886858004
886858011
Model or catalog number
72401850
Companies
- Manufacturer
-
American Medical Systems Inc.
10700 Bren Road West
Minnetonka
55343
Minnesota
UNITED STATES