Cardinal Health Surgery Packs (2020-01-31)

Starting date:
January 31, 2020
Posting date:
February 11, 2020
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-72307

Last updated:

Affected Products

  1. Cardiac Catheterization Pack
  2. Health Science Centre - Sterile Coronary Custom Pack
  3. Custom Sterile Pacemaker
  4. Orthopaedic Pack
  5. General Surgery Pack
  6. Minor Packs
  7. Laparoscopy Packs
  8. Facial Plastics Plus Packs
  9. Catheterization Packs
  10. Fistula Packs
  11. Urology Packs
  12. Angiography Pack
  13. Breast Packs
  14. Vascular Pack
  15. Coronary Pack
  16. Thoracic Pack
  17. General Cardiovascular Pack
  18. General Plastic Surgery Packs
  19. Major Surgery Packs
  20. Thoracic Pack
  21. Breast Biopsy Packs
  22. Vascular Pack
  23. Abdominal Pack
  24. Plastic Limb Packs
  25. Fistula Kits
  26. Vascular Limb Kits
  27. Ear Kits
  28. Laparotomy/Laparoscopy Packs
  29. Throat/Tonsil Packs
  30. Pacemaker Packs
  31. Minor Breast Kits
  32. Carotid Endarterectomy Kits
  33. Basic Plastic Packs
  34. Bone Marrow Biopsy Packs
  35. Radiology Tray
  36. Cardiac Implant Pack
  37. Chest Opening Packs
  38. Endarterectomy Packs
  39. Lung Transplant Kit
  40. Trachea/Thyroid Packs
  41. Peripherally Inserted Central Catheter (PICC) Line Insertion Packs
  42. Obstetrics And Gynaecology (OB/GYN) Packs
  43. Peripherally Inserted Central Catheter (PICC) Line Kits
  44. Transurtheral Resection Of The Prostate (TURP) Packs
  45. Video Assisted Thoracoscopic Surgery (VATS) Packs
  46. Robotic Surgery (Chirurgie Robotique) Packs
  47. Oculoplasty Packs
  48. Thyroid Kits
  49. Major Vascular Kits
  50. Major Neck Kits
  51. Neck Kits
  52. Urology Packs
  53. Plastic Extremity Packs
  54. Opthalmology
  55. Basic Ear/Nose/Throat (Ent) Packs
  56. Hepatopancreaticobiliary (HPB) Kits
  57. Bypass (Pontage) Packs

Reason

Cardinal Health initiated the surgical gown voluntary recall because some of the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not qualified by Cardinal Health and commingled with properly manufactured gowns.

Affected products

  1. Cardiac Catheterization Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • SAN30PC'XXX'
  • SCV30LBXXX
Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

B. Health Science Centre - Sterile Coronary Custom Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SCV30COXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

C. Custom Sterile Pacemaker

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SAN30PCXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

D. Orthopaedic Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PO30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

E. General Surgery Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PO30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

F. Minor Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PW30IP'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

G. Laparoscopy Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PB30LS'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

H. Facial Plastics Plus Packs

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PW30PL'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

I. Catheterization Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SCV30LB'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

J. Fistula Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30AV'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

K. Urology Packs

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PU30BC'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

L. Angiography Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SCV30COXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

M. Breast Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30MJ'XXX'
PG30MJPHB
PG30MJPHC

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

N. Vascular Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30LV'XXX'
PV30LVGTB
PV30LVGTC

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

O. Coronary Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SCV30COXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

P. Thoracic Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PH30MJ'XXX'
PH30MJGTC
PH30TS'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

Q. General Cardiovascular Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PC30OT'XXX'
PC30VP'XXX'
PC30VPGTD

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

R. General Plastic Surgery Packs

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PW30AP'XXX'
PW30APGTB
PW30APGTC

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

S. Major Surgery Packs

Lot or serial number

Plus de 10 numéros, contactez le fabricant.

Model or catalog number

PD30LT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

T. Thoracic Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PH30MJ'XXX'
PH30MJGTC
PH30TS'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

U. Breast Biopsy Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30BB'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

V. Vascular Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30LV'XXX'
PV30LVGTB
PV30LVGTC

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

W. Abdominal Pack

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PG30MJ'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

X. Plastic Limb Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PO30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

Y. Fistula Kits

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PV30AV'XXX'
PV30AVGTB

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

Z. Vascular Limb Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30LV'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AA. Ear Kits

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PE30EA'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AB. Laparotomy/Laparoscopy Packs

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PB30LS'XXX'
PB30LSGTB

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AC. Throat/Tonsil Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30TH'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AD. Pacemaker Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30PK'XXX'
PV30PKGTB
SAN30PCXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AE. Minor Breast Kits

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

PW30BJ'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AF. Carotid Endarterectomy Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30CA'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AG. Basic Plastic Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PW30PLXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AH. Bone Marrow Biopsy Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PO30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AI. Radiology Tray

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SAN30PC'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AJ. Cardiac Implant Pack

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PC30VP'XXX'
PC30VPGTE
PC30VPGTF

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AK. Chest Opening Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PC30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AL. Endarterectomy Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30CA'XXX'
PV30CAGTC

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AM. Lung Transplant Kit

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PD30LTGTD
PD30LTGTF
PD30LTXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AN. Trachea/Thyroid Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30THXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AO. Peripherally Inserted Central Catheter (PICC) Line Insertion Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SAN30PC'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AP. Obstetrics And Gynaecology (OB/GYN) Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

Not applicable.

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AQ. Peripherally Inserted Central Catheter (PICC) Line Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

Sans objet.

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AR. Transurtheral Resection Of The Prostate (TURP) Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PU30TR'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AS. Video Assisted Thoracoscopic Surgery (VATS) Packs

Lot or serial number

Plus de 10 numéros, contactez le fabricant.

Model or catalog number

PH30TS'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AT. Robotic Surgery (Chirurgie Robotique) Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30MC'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AU. Oculoplasty Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PQ30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AV. Thyroid Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PE30THGTC
PG30TH'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AW. Major Vascular Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PV30MJ'XXX'
PV30MJGTB
PV30MJGTD

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AX. Major Neck Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PE30HMGTC
PE30HMGTD
PE30HMXXX
PE30HNGTD

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AY. Neck Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PE30HNGTB
PE30HNGTC
PE30HNGTE
PE30HNXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

AZ. Urology Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PU30OTGTB
PU30OTGTC
PU30OTXXX
PU30TR'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

BA. Plastic Extremity Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

BB. Opthalmology

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PQ30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

BC. Basic Ear/Nose/Throat (Ent) Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PE30HM'XXX'
PE30HN'XXX'
PG30OT'XXX'

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

BD. Hepatopancreaticobiliary (HPB) Kits

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PG30THXXX

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

BE. Bypass (Pontage) Packs

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PC30CA'XXX'
PC30CG'XXX'
PC30CGGTE
PC30CGGTG

Companies
Manufacturer
Cardinal Health
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES