Health product recall

Cardinal Healths' Presource Kits (2018-03-06)

Starting date:
March 6, 2018
Posting date:
March 21, 2018
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-66198

Affected products

A. CATHETERIZATION PACK
B. LAP CHOLE PACKS
C. KNEE PACKS
D. CARDIAC CATHETERIZATION PACKS
E. MINOR LAPAROTOMY PACKS
F. ENSEMBLE CORONARY
G. MAXIMAL BARRIER
H. EP PACK
I. C SECTION PACK
J. ENSEMBLE PACEMAKER
K. MINOR LITHOTONY PACKS
L. MAJOR LAPAROTOMY PACKS
M. TRANSVERSE LAPAROTOMY PACKS

Reason

Cardinal health presource kits were exposed to temperature variations during transportation which are outside the range of the supplier's approved labelling. As such, these temperature excursions may have impacted the effectiveness of certain components within the kits.

Affected products

A. CATHETERIZATION PACK

Lot or serial number

468183

Model or catalog number

SAN30CLJGG

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

B. LAP CHOLE PACKS

Lot or serial number

468653

Model or catalog number

SLC30LCNLF

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

C. KNEE PACKS

Lot or serial number

468249

Model or catalog number

SOP30TKRMC

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

D. CARDIAC CATHETERIZATION PACKS

Lot or serial number

468238
468563
468870
469135

Model or catalog number

SAN30CCSLH
SAN30CCUA1
SAN30CLCRE
SAN30CLSLR
 

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

E. MINOR LAPAROTOMY PACKS

Lot or serial number

469042

Model or catalog number

SBA30MNNLE

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

F. ENSEMBLE CORONARY

Lot or serial number

469013

Model or catalog number

SAN30ECVOD

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

G. MAXIMAL BARRIER

Lot or serial number

468720

Model or catalog number

SBA30MBKGA

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

H. EP PACK

Lot or serial number

467711

Model or catalog number

SCV30EPUA1

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

I. C SECTION PACK

Lot or serial number

467754
468174
469012

Model or catalog number

SMA30CSLBM
SMA30CSPLF
SMA30CSSDC
 

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

J. ENSEMBLE PACEMAKER

Lot or serial number

468173

Model or catalog number

SCV30PCUAE

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

K. MINOR LITHOTONY PACKS

Lot or serial number

468401

Model or catalog number

SBA30LTNLE

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

L. MAJOR LAPAROTOMY PACKS

Lot or serial number

468337

Model or catalog number

SBA30MLNLE

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES

M. TRANSVERSE LAPAROTOMY PACKS

Lot or serial number

467489

Model or catalog number

SBA30TRNHJ

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

Illinois

UNITED STATES