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Health product recall

BD PosiFlush T Pre-Filled Saline 10ml Syringe part of Cardinal Health Presource Kit (2014-07-31)

Starting date:
July 31, 2014
Posting date:
August 15, 2014
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-41041

Recalled products

  1. Ensemble Sterile Central Line
  2. Sterile Catheterization Radial Pack
  3. Ens. External Ventricular  Drain
  4. Sterile PICC Line Insertion Kit
  5. Str Central Line Insertion Kit
  6. Pacemaker Pack

Reason

BD has initiated an urgent product recall of the component 306553, the BD PosiFlush T Saline Flush Syringe 10ml lots 4128353, 3046276 and 3024261. Some unit packages may exhibit open seals which impacts package integrity and potentially product sterility. These syringes are found in Cardinal Health Presource Kits.

Affected products

A. Ensemble Sterile Central Line

Lot or serial number
  • 150449
  • 153909
  • 155940
  • 158493
  • 162636
  • 164042
Model or catalog number
  • SAN30CLJGG
  • SAN30CLMGB
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

B. Sterile Catheterization Radial Pack

Lot or serial number
  • 160621
Model or catalog number
  • SAN30CCSNA
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

C. Ens. External Ventricular  Drain

Lot or serial number
  • 150796
Model or catalog number
  • SCV30EVMGB
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

D. Sterile PICC Line Insertion Kit

Lot or serial number
  • 155874
  • 164007
Model or catalog number
  • SAN30PIGRB
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

E. Str Central Line Insertion Kit

Lot or serial number
  • 150538
  • 155246
Model or catalog number
  • SAN30CLHMA
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

F. Pacemaker Pack

Lot or serial number
  • 153953
  • 158842
  • 159524
  • 165115
  • 212412
Model or catalog number
  • SAN30PCSNB
  • SAN30PLRGB
  • SAN30PLRGC
Companies
Manufacturer
Cardinal Health
1430 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

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