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:
2021-05-26
Affected Products
- Heart Biopsy Post Transplant Packs
- Catheterization Packs
- Angiography Pack
- Radiology Tray
- Cardiac Implant Pack
- Percutaneous Angioplasty Packs
- Cardiac Electrophysiology (Ep) Packs
- Cardiac Ablation Packs (Ensemble Ablation)
- Caesarian (C) Section Packs
- 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