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Health product recall

All Presource Kits Supplied by Zhende, Distributed by Cardinal Health (2017-11-13)

Starting date:
November 13, 2017
Posting date:
December 14, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-65398

Affected products

Trade Name Model or catalog number
A. ORTHOPAEDIC Presource Kit 
  • SOP30IMCBG
B. GENERAL SURGERY Presource Kits
  • SBA30GNOTB
  • SBA30LIOSD
  • SBA30LTQEG
C. SPECIAL PROCEDURE Presource Kits
  • SPP99DE2AA
  • SPP99DE3AA
D. PEDIATRIC Presource KitS
  • SBA30EPVHF
E. Major Pack Presource Kits
  • SBA30ABGBC
  • SBA30ABMGA
  • SBA30LPJGK
  • SBA30MGROJ
F. Minor Pack Presource Kits
  • SBA30MBJGG
  • SBA30MICRB
  • SBA30MINH1
  • SBA30MNCBM
  • SBA30MNGBD
  • SBA30MNGBE
  • SBA30MNRVH
  • SBA30MONRD
  • SBA30MOQEL
  • SBA30MPVIF
  • SBA30MSNRJ
G. Lap Chole Presource Kits
  • SBA30LCRMS
  • SBA30LCSDB
  • SBA30LPSXD
  • SLC30LCCBJ
  • SLC30LCOSC
  • SLC30LCSMF
  • SLC30LCSYD
H. Laparoscopy Presource Kits
  • SBA30LABVD
  • SBA30LSGBD
  • SLC30LCNRK
  • SLC30LPCLB
  • SLC30LPCWH
  • SLC30LPNRM
  • SLC30LPOTB
  • SLC30LPTTD
  • SLC30LSJGM
  • SMA30LASLH
  • SMA30MLVHG
I. Hemhoroid procedure Presource Kits
  • SBA30HMSLK
J. Facial Plastics Presource Kits
  • SEN30LFDTE
K. Laparotomy Packs Presource Kits
  • SBA30PESDC
L. Arthroscopic Presource Kits
  • SOP30APCCC
  • SOP30APMKJ
  • SOP30ARKSG
  • SOP30ARRMU
  • SOP30ARWPB
  • SOP30AYOTF
  • SOP30SPMSD
  • SOP30TAQEI
M. Knee packs Presource Kits
  • SOP30KNQEK
  • SOP30KNSMI
  • SOP30TKGBG
  • SOP30TKSLK
  • SOP30TKSXD
  • SOP30TKTTE
N. Presource Kits -Vein Packs
  • SAN30CVKWA
O. Presource Kits- catherization packs
  • SAN30CCSLH
  • SAN30CLSLR
  • SCV30LBVHL
P. Presource Kits-Split pack
  • SOP30MSNHH
  • SOP30MSRGB
  • SOP30MSWOB
Q. Presource Kits- Basin Set
  • SUT30PEIWD
R. Presource Kits-Endoscopy Packs
  • SBA30EHWDB
S. Presource Kits-Basic Ent Pack
  • SEN30EENRG
  • SEN30EESMB
  • SEN30ENBUB
  • SEN30ENCRB
  • SEN30ENRHJ
T. Presource Kits-Urology Packs
  • SBA30MGBCH
  • SBA30UGRVM
  • SBA30UGRVN
  • SOT30URVGC
U. Presource Kits-Thoracotomy Pack
  • SBA30TCGBD
  • SBA30TCQEK
  • SBA30TCSLK
  • SBA30THSLJ
  • SBA30THVIB
V. Presource Kits-Hysteroscopy Pack
  • SMA30HSAGB
  • SMA30HSOTE
  • SMA30HSSLG
W. Presource Kits-Shoulder Pack
  • SOP30OSGBF
  • SOP30SHNOE
  • SOP30SHSIB
  • SOP30SHSXB
  • SOP30SPNRD
X. Presource Kits- Breast Packs
  • SBA30AMMSG
  • SBA30BBRVE
  • SBA30BRAPG
  • SBA30BRIWE
  • SBA30MYVHF
  • SBA30PMRVA
Y. Presource Kits-LAPARATOMY/LAPAROSCOPY PACKS
  • SBA30LASAD
  • SBA30LMRGA
  • SBA30LPRVN
  • SBA30MLPAE
  • SBA30MNHWG
  • SLC30LAVHI
  • SLC30LCPNB
Z. Presource Kits-FACIAL SURGERY PACKS
  • SBA30FCKPA
AA. Presource Kits-ANGIOGRAPHY PACK
  • SAN30ESSCH
  • SAN30XRWHD
AB. Presource Kits - Vascular Pack
  • SCV30EVVHG
  • SCV30MNUHB
  • SCV30VAOTC
  • SCV30VLOTC
AC. Presource Kits- Thoracic Pack
  • SBA30THHML
  • SCV30MCROK
  • SCV30STQEF
  • SCV30THRHM
  • SCV30TVFHJ
AD. Presource Kits-AORTA/ANEURYSM PACK
  • SBA30AAVHL
  • SCV30AADTD
  • SCV30AAOHB
  • SCV30AARCA
  • SCV30AASLG
  • SCV30AAVGB
  • SCV30AAVR2
  • SCV30DDOHB
AE. Presource Kits-BY-PASS PACK
  • SCV30OHKGG
AF. Presource Kits-GENERAL CARDIOVASCULAR PACK
  • SCV30CBUH5
  • SCV30CBUHU
  • SCV30CPQUE
  • SCV30CUGHL
  • SCV30LO342
  • SCV30LO343
  • SCV30LO34A
AG. Presource Kits-Heart Pack
  • SCV30PDOAE
  • SCV30PDVHA
  • SCV30VPRCA
AH. Presource Kits-GENERAL PLASTIC SURGERY PACKS
  • SBA30LIQEG
AI. Presource Kits-MINOR SURGERY PACKS
  • SBA30MIPNC
  • SLC30MNOTB
  • SMA30CRIWF
  • SSK1003
AJ. Presource Kits - MAJOR SURGERY PACKS
  • SBA30BSRMH
  • SBA30LPROF
  • SBA30MAPNB
  • SBA30MBYKF
  • SBA30MJEGF
  • SNE30BSMUB
  • SSK2001
AK. Presource Kits- ABDOMINAL PACKS
  • SBA30ABKGI
  • SBA30APRMD
  • SBA30MACHC
  • SBA30MJCHC
AL. Presource Kits-DRESSING PACK
  • SBA30VAPNB
  • SBA30VAVEB
AM. Presource Kits-IP CHEMO PACK
  • SBA30CVCHC
AN. Presource Kits-EP PACK
  • SCV30EPSLG
AO. Presource Kits-BREAST BIOPSY PACKS
  • SBA30BBSLK
AP. Presource Kits- C Section Pack
  • SMA30CCBGB
  • SMA30CCGHH
  • SMA30CDNFB
  • SMA30CEGBF
  • SMA30CEMAD
  • SMA30CSCBM
  • SMA30CSOSE
  • SMA30CSOTL
  • SMA30CSSLE
  • SMA30CSSVG
  • SMA30CSTTD
  • SMA30CSYOC
AQ. Presource Kits-UPPER EXTREMITY PACK
  • SOP30UPGBD
  • SOP30UPNHI
  • SOP30XTSLE
AR. Presource Kits -IUD TRAY
  • 09-0562B
AS. Presource Kits-ENT NOSE PACK
  • SEN30NSRVG
  • SEN30NSRVH
AT. Presource Kits-NASAL PACKING
  • 24-3306
AU. Presource Kits-ORTHO EXTREMITY PACK
  • SOP30LBOSF
  • SOP30LBTTC
AV. Presource Kits-HAND PACK
  • SBA30CTQUD
  • SBA30CTSXC
  • SOP30HADHA
  • SOP30HNLBN
  • SOP30HNSLF
AW. Presource Kits-LEFT HEMICOLECTOMY LAP PACK
  • SBA30LLSLH
AX. Presource Kits- Breast Pack
  • SBA30BRCBF
  • SBA30BRLBT
  • SBA30BRSLF
  • SBA30PBQEH
AY. Presource Kits-THORACOSCOPY PACK
  • SCV30MCBCF
AZ. Presource Kits-ENSEMBLE PACEMAKER
  • SAN30PAWOD
  • SCV30PMRGA
  • SCV30PMVGB
BA. Presource Kits-OPEN HEART PACK
  • SCV30OHQES
  • SCV30OHVHB
  • SCV30OHVHC
BB. Presource Kits-TUBAL LIGATION PACK
  • SMA30LICMB
BC. Presource Kits-Extremity Pack
  • SOP30EPNRG
  • SOP30EXCCC
  • SOP30EXSXD
  • SOP30XRNR2
  • SOP30XTAGC
  • SOP30XTNR1
  • SOP30XTSVG
BD. Presource Kits-Tonsil Pack
  • SEN30TNOTD
BE. Presource Kits-TVT Pack
  • SMA30TVQEH
BF. Presource Kits-Joint Pack
  • SOP30TJCBN
BG. Presource Kits-Sinus Pack
  • SEN30SISLK
  • SEN30SISPB
  • SEN30SISPC
BH. Presource Kits-Ensemble Fem pop
  • SCV30FEARA
BI. Presource Kits - Ensemble Ablation
  • SAN30EASCC
BJ. Presource Kits- Vascular Pack
  • SCV30AVGNF
  • SCV30VSQEH
BK. Presource Kits-Abdominal Pack
  • SBA30ABOBF
  • SBA30ABOSG
  • SBA30ABPLN
  • SBA30ABWHA
  • SBA30HYRMO
  • SBA30MANOE
  • SBA30MAQEJ
  • SBA30MASXD
  • SBA30MATTE
  • SBA30MJCBM
  • SBA30MJMDJ
  • SBA30MJMKN
  • SBA30MJQEM
  • SBA30MJUNH
  • SBA30MJVHH
  • SBA30MNOSB
  • SBA30MNQEI
  • SBA30MNSXD
  • SBA30MNVHF
  • SBA30PCRYF
  • SBA30PCRYG
  • SLC30MJOTA
BL. Presource Kits- Vats Pack
  • SBA30VACVC
  • SBA30VAQEJ
BM. Presource Kits-FEMORAL XRAY PACK
  • SAN30BSWHC
BN. Presource Kits-TURP PACK
  • SBA30TPMKH
BO. Presource Kits-MANIFOLD PACKS
  • SAN30MNSCC
BP. Presource Kits-MAJOR CARDIOVASCULAR PACKS
  • SCV30MANHJ
BQ. Presource Kits-PICC LINE INSERTION PACKS
  • SAN30PCWHC
  • SAN30PPQEG
BR. Presource Kits-CENTRAL LINE INSERTION PACKS
  • SAN30CLCHB
  • SAN30LICWD
BS. Presource Kits-LOWER EXTREMITY PACKS
  • SOP30LESLE
  • SOP30MINHJ
BT. Presource Kits-ACL Packs
  • SOP30ACDTG
  • SOP30ACKSF
  • SOP30ACOTB
  • SOP30ACQUF
  • SOP30ACSMG
BU. Presource Kits-KNEE ARTHROSCOPY PACKS
  • SOP30APSLH
  • SOP30ARTTD
  • SOP30KANRF
  • SOP30KASJL
  • SOP30KASSA
  • SOP30LAGBG
  • SOP30SASXE
BV.Presource Kits-MINOR ORTHO PACKS
  • SOP30BOSSA
  • SOP30MNCBK
  • SOP30MORML
  • SOP30OMBEB
  • SOP30ORSLC
  • SOP30SPSXB
BW. Presource Kits - SHOULDER ARATHROSCOPY PACKS
  • SOP30SAGBE
  • SOP30SAKSF
  • SOP30SAOPE
  • SOP30SAROF
  • SOP30SASLI
  • SOP30SHBTC
  • SOP30SHGBA
  • SOP30SHRMC
  • SOP30SHVRH
BX. Presource Kits - Total Hip Packs
  • SOP30THGBG
  • SOP30THNH2
  • SOP30THNHN
  • SOP30THSLJ
  • SOP30THSXD
  • SOP30THTTE
BY. Presource Kits-DHS Packs
  • SOP30DHCBI
BZ. Presource Kits-PLASTIC LIMB PACKS
  • SOP30LAHEA
CA. Presource Kits- THYROID KITS
  • SEN30THSLB
CB. Presource Kits - EAR KITS
  • PE30EAGTA
CC. Presource Kits- Knee Packs
  • SOP30KAPGC
CD. Presource Kits - VASCULAR/THORACOTOMY PACKS
  • SOP30TCCVC
CE. Presource Kits- Hip Packs
  • SOP30HPDTM
CF. Presource Kits-SHOULDER PACKS
  • SOP30BCMSC
CG. Presource Kits-ABDOMINAL HYSTERECTOMY PACKS
  • SMA30AHSLF
  • SMA30CHCVR
CH. Presource Kits - GENERAL GYNE PACKS
  • PB30MJGTA
  • SMA30GHPNC
  • SMA30GLQCB
  • SMA30GLRVC
  • SMA30MPRMJ
  • SMA30PLNHH
  • SMA30VGIWK
  • SOT30TVSXD
CI. Presource Kits- LABOUR & DELIVERY PACK
  • SMA30CSPNB
  • SMA30PGVRK
CJ. Presource Kits- LAPAROTOMY/LAPAROSCOPY PACKS
  • PB30LSGTA
  • SMA30LARVM
CK. Presource Kits-DENTAL PACKS
  • SEN30MJOTC
  • SEN30MODTD
CL. Presource Kits- Ear Packs
  • SEN30MYHMQ
CM. Presource Kits- HEAD AND NECK PACKS
  • SEN30NPQEL
CN. Presource Kits- ORAL PACKS
  • SEN30ORVRH
CO. Presource Kits- THROAT/TONSIL PACKS
  • SEN30THOTE
  • SEN30TPVOB
CP. Presource Kits-BOWEL RESECTION PACKS
  • SBA30BSSMC
  • SBA30GPRVK
  • SOT30BANOD
CQ. Presource Kits-BOWEL RESECTION-LITHOTOMY PACKS
  • SBA30BLRVC
CR. Presource Kits-LAPAROTOMY/LAPAROSCOPY PACKS
  • SBA30MLVRG
  • SLC30LASLK
  • SLC30LCHMO
  • SLC30LCHWI
  • SLC30LCQEL
  • SLC30LCSVG
CS. Presource Kits -CABG Packs
  • SCV30CBRCB
  • SCV30CBRHZ
CT. Presource Kits -FEM POP PACKS
  • SCV30CAOHB
  • SCV30FPRVN
CU. Presource Kits -PACEMAKER PACKS
  • SAN30PANRG
CV. Presource Kits- NEUROLOGY PACKS
  • SNE30BSUHB
  • SNE30NEUHD
CW. Presource Kits-CRANIOTOMY PACKS
  • SNE30CNRCA
  • SNE30CRUHR
  • SNE30CRVCN
  • SNE30CRVHC
CX. Presource KitS-HEAD AND NECK PACKS
  • SEN30HNVHG
CY. Presource Kits - spinal packs
  • SEN30BPQEH
  • SNE30LDUHK
  • SNE30SPUHB
  • SOP30SPVHJ
CZ. Presource Kits -VP SHUNT PACKS
  • SNE30SHUHD
DA. Presource Kits - LIVER TRANSPLANT KITS
  • SBA30LVHML
  • SBA30MJUAO
DB. Presource Kits-RADICAL PROSTATE PACKS
  • SOT30RPNOG
  • SOT30RPPBH
  • SOT30RPRVK
  • SOT30RPRVL
  • SOT30RPSLD
DC. Presource Kits -ABDOMINAL LITHOTOMY PACKS
  • SBA30LIUHE
DD. Presource Kits- CYSTOSCOPY PACKS
  • SBA30CPMKG
DE. Presource Kits -KIDNEY PACKS
  • SBA30KDHNK
  • SBA30KRUAG
  • SBA30NPPBF
  • SNU30KTQEL
  • SOT30KDCHB
  • SOT30PEQEF
  • SOT30PESJB
DF. Presource Kits - OB/GYN PACKS
  • SMA30OBDLE
  • SMA30OBPNG
DG. Presource Kits - LABOUR AND DELIVERY PACKS
  • SMA30BPRVD
  • SMA30BPSVD
  • SMA30CNRVK
  • SMA30DEABE
  • SMA30DEAGD
  • SMA30LDQUD
  • SMA30VDOTA
DH. Presource Kits-  GENERAL GYNECO LAPRAOSCOPIE PACKS
  • SLC30GLPNC
  • SLC30GLSVA
  • SLC30GLWHB
  • SLC30GYOSB
  • SMA30GLAGB
  • SMA30GLNH1
  • SMA30GLNHJ
  • SMA30GLOTA
  • SMA30GLPBJ
  • SMA30GLQUC
  • SMA30GLTTC
  • SMA30GLVI1
  • SMA30GLVI2
  • SMA30LPNFA
  • SMA30LPRMI
  • SMA30LPSSG
  • SMA30LPVHF
  • SMA30LSOTD
  • SMA30LSRVO
DI. Presource Kits-GYNECO MAJOR PACKS
  • SMA30ABPND
  • SMA30GYWHA
DJ. Presource Kits - HARMONIZED PFANNENSTIEL PACKS
  • SBA30LCIHB
  • SMA30HYBCA
  • SMA30HYFHA
DK. Presource Kits - HYSTERECTOMY PACKS
  • SMA30AHMDK
  • SMA30AHVHH
  • SMA30HVOTC
  • SMA30HYJUB
  • SMA30HYQEE
  • SMA30HYVHF
  • SMA30LANRH
  • SMA30LATTD
  • SMA30VGSLI
DL. Presource Kits-D AND C PACKS
  • SMA30DCSVF
DM. Presource Kits-PERI GYN LITOTOMIE PACKS
  • SMA30PEQEH
  • SMA30PGQEC
  • SMA30VGGIWL
DN. Presource Kits - HARMONIZED MINOR MIS GYNE PACKS
  • SMA30MNBCA
  • SMA30MNFHA
  • SMA30MNIHC
DO. Presource Kits -ENDOMETRIAL ABLATION PACKS
  • SMA30ENQUC
  • SMA30ENSSD
  • SMA30ENVIA
DP. Presource KitS-LSR PROSTATE URETEROSCOPY CYSTO PACKS
  • SOT30PEDLH
DQ. Presource Kits-MINOR UROLOGY PACKS
  • SBA30MNBCH
  • SBA30MUSLD
DR. Presource Kits -LOCAL CYSTO PACKS
  • SBA30CYGBF
  • SBA30CYRVI
  • SBA30CYSLA
  • SBA30CYSXC
  • SBA30CYWHE
  • SOT30CYCWB
  • SOT30CYGHG
  • SOT30URNH1
DS. Presource Kits -HARMONIZED MAJOR MIS LITHOTOMY PACKS
  • SBA30LICLE
  • SBA30LISDG
  • SBA30LIVHJ
  • SMA30LIVHG
DT. Presource Kits - BOWEL RESECTION LITHOTOMY PACKS
  • SBA30CRCHG
  • SBA30CRUCI
DU. Presource Kits-FACIAL BUNDLE PASQUA PACKS
  • SBA30FARCA
DV. Presource Kits- BASIC PLASTIC PACKS
  • SBA30PLGBA
  • SBA30PLNTE
DW. Presource Kits-LARGE LAP PACKS
  • SBA30LLGBE
DX. Presource Kits-MAJOR LAPAROTOMY PACKS
  • SBA30LAFHB
  • SBA30LPHMI
  • SBA30LPSCB
  • SBA30LPSLK
  • SBA30LPVI1
  • SBA30MLBTC
  • SBA30MLLBO
  • SBA30MLNHM
  • SBA30MLSJJ
  • SCV30SPNGL
DY. Presource Kits-TRANSVERSE LAPAROTOMY PACKS
  • SBA30TRNHJ
DZ. Presource Kits-SEPTOPLASTY PROCEDURAL PACKS
  • SEN30SESSD
  • SEN30SPSLC
EA. Presource Kits-NASAL SURGERY PACK
  • SEN30NAHRF
  • SEN30NAKGD
  • SEN30NARGA
  • SEN30NAROH
EB. Presource Kits-ENSEMBLE BASIC MIDDLE EAR
  • SEN30EAKGA
  • SEN30EATHE
  • SEN30EAVGQ
  • SEN30TYHMS
EC. Presource Kits-FESS PACKS
  • SEN30FEOTC
  • SEN30FEVRI
ED. Presource Kits - NOSE PACKS
  • SEN30NOQGI
EE. Presource Kits -MAXILLO MAJOR PACKS
  • SEN30MFHRD
EF. Presource Kits -DENTAL PROCEDURES PACKS
  • SEN30DNHMH
  • SEN30DNPBE
  • SEN30DNTTE
  • SEN30DNVHB
  • SEN30DNVIC
  • SEN30DNWUA
  • SEN30DSLRJ
  • SEN30DTTTE
EG. Presource Kits -UNIVERSAL SPLIT PACKS
  • SBA30UNFHA
  • SBA30UNNHI
  • SBA30UNOSE
  • SBA30UPSDD
  • SBE30UNBCA
EH. Presource Kits-MEDIASTINOSCOPY TRACHEOSTOMY PACKS
  • SBA30BYSLF
  • SBA30MTQEH
EI. Presource Kits-VAGINAL HYSTERECTOMY PACK
  • SMA30VHNRM
  • SMA30VHOTA
  • SMA30VHSLH
EJ. Presource Kits-LOCATOR BIOHORIZONS INTERNAL
  • SBA30HNSLI
EK. Presource Kits-LOCATOR SCREW VENT.COMPATIBLES RP
  • SBA30REVHF
EL. Presource Kits-LOCATOR INTEGRAL/COMPATIBLES
  • SBA30RBJGO
EM. Presource Kit-HEAT SHOCK PROTEIN
  • SBA30NPQEM
  • SBA30VSROG
EN. Presource Kits-RADIOLOGY TRAY
  • SAN30ITOHA
  • SAN30PCGMB
EO. Presource Kits-ENSEMBLE TRAUMA
  • SBA30TALBA
EP. Presource Kits-CARDIAC IMPLANT PACK
  • SAN30CPTHD
EQ. Presource Kits-CAROTID PACKS
  • SCV30CAARA
ER. Presource Kits-HEAD PACK
  • SBA30PNVHE
ES. Presource Kits -STERILE OBSTETRICAL PACK
  • A29630
ET. STERILE OBSTETRICAL PACK-Presource Kits
  • A29850
EU. Presource Kits-STERILE OBSTETRICAL
  • A29860
EV. Presource Kits-STERILE ENSEMBLE VOIE CENTRAL
  • SAN30CVJUA
EW. Presource Kits - STERILE PROCEDURE PACK
  • SBA30MPACB
EX. Presource Kits - TERILE D C PACK
  • SMA30DCOSB
EY. Presource Kits-STERILE D C
  • SMA30DCPSC
EZ. Presource Kits-STERILE LAPAROSCOPY PACK
  • SMA30LPDTF
FA. Presource Kits-STERILE SQUAMISH OB PACK
  • SMA30OBBCA
FB. Presource Kits-STERILE DELIVERY PACK
  • SMA30VDWEJ
FC. Presource Kits-STERILE ARM HAND PACK
  • SOP30AHRVG

Reason

Cardinal Health has recently been informed that Zhende has issued a supplier device correction for 4x4" 16- Ply X-ray Gauze (CR-NXR4416) due to the potential for miscounted gauze. This gauze is found in Cardinal Health Presource Kits.

Affected products

All Presource Kits Supplied by Zhende, Distributed by Cardinal Health

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

See affected products”

Companies
Manufacturer

Cardinal Health

1500 Waukegan Road

Waukegan

60085

UNITED STATES


Date modified: