Health product recall

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