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: 2020-02-18
Affected Products
- Cardiac Catheterization Pack
- Health Science Centre - Sterile Coronary Custom Pack
- Custom Sterile Pacemaker
- Orthopaedic Pack
- General Surgery Pack
- Minor Packs
- Laparoscopy Packs
- Facial Plastics Plus Packs
- Catheterization Packs
- Fistula Packs
- Urology Packs
- Angiography Pack
- Breast Packs
- Vascular Pack
- Coronary Pack
- Thoracic Pack
- General Cardiovascular Pack
- General Plastic Surgery Packs
- Major Surgery Packs
- Thoracic Pack
- Breast Biopsy Packs
- Vascular Pack
- Abdominal Pack
- Plastic Limb Packs
- Fistula Kits
- Vascular Limb Kits
- Ear Kits
- Laparotomy/Laparoscopy Packs
- Throat/Tonsil Packs
- Pacemaker Packs
- Minor Breast Kits
- Carotid Endarterectomy Kits
- Basic Plastic Packs
- Bone Marrow Biopsy Packs
- Radiology Tray
- Cardiac Implant Pack
- Chest Opening Packs
- Endarterectomy Packs
- Lung Transplant Kit
- Trachea/Thyroid Packs
- Peripherally Inserted Central Catheter (PICC) Line Insertion Packs
- Obstetrics And Gynaecology (OB/GYN) Packs
- Peripherally Inserted Central Catheter (PICC) Line Kits
- Transurtheral Resection Of The Prostate (TURP) Packs
- Video Assisted Thoracoscopic Surgery (VATS) Packs
- Robotic Surgery (Chirurgie Robotique) Packs
- Oculoplasty Packs
- Thyroid Kits
- Major Vascular Kits
- Major Neck Kits
- Neck Kits
- Urology Packs
- Plastic Extremity Packs
- Opthalmology
- Basic Ear/Nose/Throat (Ent) Packs
- Hepatopancreaticobiliary (HPB) Kits
- 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
-
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