Unipolar Adapter 5 mm, Unipolar Adapter 6mm, Bi Polar Adapter, Cap and Sleeve Kit, and BiPolar Lead, 25CM, BiPolar lead 54CM (2018-08-31)
- Starting date:
- August 31, 2018
- Posting date:
- September 17, 2018
- 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-67770
Affected products
A. Unipolar adapter 5MM; Unipolar adapter 6MM
B. Bi Polar Adapter; Bipolar adapter dual port; Bipolar adapter, short; Bipolar adapter, accessories
C. Cap and Sleeve Kit
D. Bipolar lead, 25CM; Bipolar lead, 54CM
Reason
Implant card only had English and was missing French.
Affected products
A. Unipolar adapter 5MM; Unipolar adapter 6MM
Lot or serial number
All lots.
Model or catalog number
501203
501204
Companies
- Manufacturer
-
Greatbatch Medical
2300 Berkshire Lane North
Minneapolis
55441
Minnesota
UNITED STATES
B. Bi Polar Adapter; Bipolar adapter dual port; Bipolar adapter, short; Bipolar adapter, accessories
Lot or serial number
All lots.
Model or catalog number
501205
501206
501214
Companies
- Manufacturer
-
Greatbatch Medical
2300 Berkshire Lane North
Minneapolis
55441
Minnesota
UNITED STATES
C. Cap and Sleeve Kit
Lot or serial number
All lots.
Model or catalog number
501207
Companies
- Manufacturer
-
Greatbatch Medical
2300 Berkshire Lane North
Minneapolis
55441
Minnesota
UNITED STATES
D. Bipolar lead, 25CM; Bipolar lead, 54CM
Lot or serial number
All lots.
Model or catalog number
511210
511211
511212
Companies
- Manufacturer
-
Greatbatch Medical
2300 Berkshire Lane North
Minneapolis
55441
Minnesota
UNITED STATES