Presource® Kits Containing the Cardinal Health Angiographic Drape and Cesarean Birth Drape products components (2021-05-20)

Starting date:
May 20, 2021
Posting date:
May 26, 2021
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-75669

Last updated:

Affected Products 

  1. Heart Biopsy Post Transplant Packs
  2. Catheterization Packs
  3. Angiography Pack
  4. Radiology Tray
  5. Cardiac Implant Pack
  6. Percutaneous Angioplasty Packs
  7. Cardiac Electrophysiology (Ep) Packs
  8. Cardiac Ablation Packs (Ensemble Ablation)
  9. Caesarian (C) Section Packs
  10. Peripherally Inserted Central Catheter (Picc) Line Kits

Reason

Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes to "stick", which may prevent the products from being unfolded and applied properly. Please refer to Cardinal Health recall
reference number: 2021FCA14 expansion for further details. After reviewing the potential impact of this recall on Presource Procedure Packs, Cardinal Health is initiating an Urgent Medical Device Correction on specific lots of Presource Packs produced containing the affected Cardinal Health component(s) and lot number(s).

Affected products

A. Heart Biopsy Post Transplant Packs

Lot or serial number
  • 555186
  • 563844
Model or catalog number
  • SAN30HBGTC
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

B. Catheterization Packs

Lot or serial number
  • More than 10 numbers, contact manufacturer. 
Model or catalog number
  • SAN30CLAHA
  • SAN30ITKGD
  • SCV30CCHSA
  • SCV30CCUAI
  • SCV30PTKG2
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

C. Angiography Pack

Lot or serial number
  • 556926
  • 564749
  • 573628
  • 574320
  • 586472
  • 601043
  • 603786
  • 607832
Model or catalog number
  • SAN30ANRID
  • SAN30ANVOE
  • SAN30ARHSB
  • SAN30ATVHE
  • SAN30BSPBG
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

D. Radiology Tray

Lot or serial number
  • 560788
Model or catalog number
  • SAN30IMRCB
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

E. Cardiac Implant Pack

Lot or serial number
  • 574986
  • 594845
Model or catalog number
  • PC30VPUHD
  • PC30VPUHE
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

F. Percutaneous Angioplasty Packs

Lot or serial number
  • 556101
  • 596487
Model or catalog number
  • SCV30PDVHA
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

G. Cardiac Electrophysiology (Ep) Packs

Lot or serial number
  • 507786
  • 557563
  • 584734
  • 615404
Model or catalog number
  • SAN30EPGTB
  • SCV30EPHSA
  • SCV30EPUAC
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

H. Cardiac Ablation Packs (Ensemble Ablation)

Lot or serial number
  • 583339
Model or catalog number
  • SCV30ANCMF
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

I. Caesarian (C) Section Packs

Lot or serial number
  • 518085
Model or catalog number
  • SMA30CSSDG
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES

J. Peripherally Inserted Central Catheter (Picc) Line Kits

Lot or serial number
  • 498141
Model or catalog number
  • SAN30PCICB
Companies
Manufacturer
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES