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Health product recall

Mobicath Bi-Directional Guiding Sheath

Starting date:
February 21, 2017
Posting date:
March 10, 2017
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-62530

Reason

Greatbatch Medical, the manufacturer of Mobicath Bi-Directional Guiding Sheaths, is conducting a global voluntary field removal following the discovery of a pouch seal integrity issue with specific lots of Mobicath Bi-Directional Guiding Sheath, Large Curve Product (Catalogue number: d140011) and Small Curve Product (Catalogue number: d140010).

Affected products

Mobicath Bi-Directional Guiding Sheath

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

  • D-1400-10
  • D-1400-11

Companies

Manufacturer
Greatbatch Medical
2300 Berkshire Lane North
Minneapolis
55441
Minnesota
UNITED STATES