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Health product recall

GEM FLOW COUPLER (2016-04-28)

Starting date:
April 28, 2016
Posting date:
May 16, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-58392

Affected products

  1. GEM FLOW COUPLER

Reason

Synovis Micro Companies Alliance is issuing a product recall for the potential for a puncture through the outer Tyvek lid of the sterile flow coupler tray-in-tray package.

Affected products

A. GEM FLOW COUPLER

Lot or serial number
  • SP15H05-1067843
  • SP15J15-1087744
  • SP15J22-1090024
  • SP15K02-1092807
  • SP15K05-1094463
  • SP15K05-1094466
  • SP15K10-1096021
  • SP15L02-1102423
Model or catalog number
  • GEM2752-FC
  • GEM2753-FC
  • GEM2754-FC
Companies
Manufacturer
SYNOVIS MICRO COMPANIES ALLIANCE INC/A SUB. OF SYNOVIS LIFE TECH. INC
439 INDUSTRIAL LANE
BIRMINGHAM
35211
Alabama
UNITED STATES

Date modified: