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Health product recall

Arterial Needles

Starting date:
May 25, 2017
Posting date:
June 13, 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-63618

Reason

Argon Medical is conducting a recall to notify customers of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. The risk is limited to any products packaged on December 15, 2016. The expected rate of defect is mall and the type of defect is visible with the naked eye. The product literature warns the user to not use this product if the packaging is opened or damaged.

Affected products

Arterial Needles

Lot or serial number

  • 11160912
  • 11160990
  • 11161729

Model or catalog number

  • 195322
  • 195352
  • 195355

Companies

Manufacturer
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES