Health product recall

GENERAL SURGERY PACK (2021-08-12)

Starting date:
August 12, 2021
Posting date:
August 24, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76291

Last updated: 2021-08-24

Affected Products 

  • A. GENERAL SURGERY PACK
  • B. CORNEA PACKS

Reason

Cardinal Health is initiating an urgent product correction on specific lots of Presource® Packs produced containing the affected Cardinal Health Monoject™ Flush Prefilled Syringes (0.9% Sodium Chloride) component due to the potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

Affected products

A. GENERAL SURGERY PACK

Lot or serial number
  • 545198
  • 570785
  • 576417
  • 578308
  • 614184
  • 639405
  • 649097
Model or catalog number

SBA30MBKGB

Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

B. CORNEA PACKS

Lot or serial number
  • 549173
  • 558847
  • 626489
Model or catalog number

SEY30CRXXX

Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES