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Health product recall

GDC- GUGLIELMI DETACHABLE COIL (2016-03-23)

Starting date:
March 23, 2016
Posting date:
April 4, 2016
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-57764

Affected Products

  1. GDC-GUGLIELMI DETACHABLE COIL - (GDC) 360 DEGREE - GDC-10 DEGREE SOFT COIL
  2. GDC-GUGLIELMI DETACHABLE COIL - (GDC) 360 DEGREE - GDC-18 360 DEGREE COIL

Reason

Stryker Neurovascular has become aware that the incorrect DFU was included with the above listed product. The general GDC DFU was added to the product instead of the GDC 360 specific DFU. Both DFU's are equivalent.

Affected products

  1. GDC-GUGLIELMI DETACHABLE COIL - (GDC) 360 DEGREE - GDC-10 DEGREE SOFT COIL

Lot or serial number
  • 17074659
Model or catalog number
  • M0033471020SR0
Companies
Manufacturer

Stryker Neurovascular

47900 Bayside Parkway

Fremont

94538

California

UNITED STATES



B. GDC-GUGLIELMI DETACHABLE COIL - (GDC) 360 DEGREE - GDC-18 360 DEGREE COIL

Lot or serial number

17469274

17614208

Model or catalog number

M00334811300

Companies
Manufacturer

Stryker Neurovascular

47900 Bayside Parkway

Fremont

94538

California

UNITED STATES