Presource® Procedure Packs (2021-02-26)
- Starting date:
- February 26, 2021
- Posting date:
- March 18, 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, Healthcare Professionals, Hospitals
- Identification number:
- RA-75141
Last updated:
2021-03-18
Affected Products
A. CARDIAC CATHETERIZATION PACK
B. BARIATRIC PACKS
C. LAPAROSCOPY PACKS
D. CATHETERIZATION PACKS
E. UROLOGY PACKS
F. ANGIOGRAPHY PACK
G. LAPARATOMY/LAPAROSCOPY PACKS
H. GENERAL CARDIOVASCULAR PACK
I. BRACHYTHERAPY PACK
J. OPEN HEART PACK
K. HYSTERECTOMY PACKS
L. BOWEL RESECTION-LITHOTOMY PACKS
M. ABDOMINAL LITHOTOMY PACKS
N. MINOR LITHOTOMY PACKS
O. BOWEL RESECTION LITHOTOMY PACKS
P. CORONARY PACKS
Q. PERCUTANEOUS ANGIOPLASTY PACKS
R. GENERAL GYNECOLOGY LAPAROSCOPY PACKS
S. GYNECOLOGY PERINEAL (PERI GYN) LITHOTOMY PACKS
T. TRANSURETHRAL RESECTION OF PROSTATE (TURP) PACK
U. AORTIC ENDOVASCULAR PACKS
V. CARDIAC ELECTROPHYSIOLOGY (EP) PACKS
W. PACEMAKER PACKS (ENSEMBLE PACEMAKER)
X. HAEMODYNAMIC PACKS (ENSEMBLE HEMODYNAMIQUE)
Y. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE INSERTION PACKS
Z. TENSION-FREE VAGINAL TAPE (TVT) PACKS
AA. OBSTETRICS AND GYNAECOLOGY (OB/GYN) PACKS
AB. ENDOMETRECTOMY PACKS
AC. DILATION AND CURETTAGE (D AND C) PACKS
AD. GENERAL GYNAECOLOGY (GYNE) PACKS
AE. TRANSOBTURATOR (TOT) PACKS
AF. LOCAL CYSTOSCOPY (CYSTO) PACKS
AG. HARMONIZED MAJOR MINIMALLY INVASIVE SURGERY (MIS) LITHOTOMY PACKS
AH. LAPAROSCOPIC SIGMOIDECTOMY (SIGMOIDECTOMIE SCOPIE) PACKS
AI. ANAL SURGERY PACKS (ENSEMBLE CHIRURGIE ANALE)
AJ. LAPAROSCOPIC ANTERIOR RESECTION (RESECTION ANTERIEURE SCOPIE) PACKS
AK. ROBOTIC SURGERY (CHIRURGIE ROBOTIQUE) PACKS
AL. PERI GYNECO 3 PACK
Reason
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to ""stick"", which may prevent the products from being unfolded and applied properly. Please refer to Cardinal Health Recall Reference Number: 2021FCA14 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. CARDIAC CATHETERIZATION PACK
Lot or serial number
518041
520163
535052
Model or catalog number
SAN30CASBA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
B. BARIATRIC PACKS
Lot or serial number
540322
Model or catalog number
SBA30BASCH
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
C. LAPAROSCOPY PACKS
Lot or serial number
544542
562940
Model or catalog number
SBA30ILJTA
SBA30LCIWA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
D. CATHETERIZATION PACKS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SAN30CARVJ
SAN30CLCR6
SAN30CLCRE
SAN30CLMHL
SAN30HCKGG
SAN30HCRJW
SAN30LHWOK
SCV30CCSBL
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
E. UROLOGY PACKS
Lot or serial number
496839
Model or catalog number
SBA30URHMD
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
F. ANGIOGRAPHY PACK
Lot or serial number
520463
556943
556976
560687
560709
Model or catalog number
SAN30AGCWC
SAN30AGQEA
SAN30ANUAP
SAN30ATSBA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
G. LAPARATOMY/LAPAROSCOPY PACKS
Lot or serial number
537538
556417
Model or catalog number
SMA30OLCVL
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
H. GENERAL CARDIOVASCULAR PACK
Lot or serial number
495892
563911
Model or catalog number
SCV30CAGHI
SCV30CAGHJ
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
I. BRACHYTHERAPY PACK
Lot or serial number
560773
Model or catalog number
SAN30BRCVE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
J. OPEN HEART PACK
Lot or serial number
519947
532293
565531
Model or catalog number
SAN30PDQEL
SCV30LHPBK
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
K. HYSTERECTOMY PACKS
Lot or serial number
533572
538991
542747
553713
Model or catalog number
SMA30HLSLA
SMA30HYGBH
SMA30VHRND
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
L. BOWEL RESECTION-LITHOTOMY PACKS
Lot or serial number
523994
560739
Model or catalog number
SBA30BLLBC
SLC30LIQED
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
M. ABDOMINAL LITHOTOMY PACKS
Lot or serial number
525082
Model or catalog number
SBA30LICPB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
N. MINOR LITHOTOMY PACKS
Lot or serial number
503487
560173
Model or catalog number
SBA30LTLBN
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
O. BOWEL RESECTION LITHOTOMY PACKS
Lot or serial number
520474
529646
Model or catalog number
SBA30CRCHH
SUT30BRPBE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
P. CORONARY PACKS
Lot or serial number
515233
556625
Model or catalog number
SAN30ECVOF
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
Q. PERCUTANEOUS ANGIOPLASTY PACKS
Lot or serial number
520475
522166
529623
529877
530471
535658
541457
Model or catalog number
SAN30AGKGA
SAN30ITQEA
SAN30PTOHA
SCV30PTOHZ
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
R. GENERAL GYNECOLOGY LAPAROSCOPY PACKS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
S. GYNECOLOGY PERINEAL (PERI GYN) LITHOTOMY PACKS
Lot or serial number
520478
533633
538358
542037
559125
Model or catalog number
SMA30EGOHC
SMA30PGQEC
SMA30PNABF
SMA30VGWOD
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
T. TRANSURETHRAL RESECTION OF PROSTATE (TURP) PACK
Lot or serial number
498411
503030
533534
Model or catalog number
SOT30RPSC4
SOT30RPSCE
SOT30TURRG
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
U. AORTIC ENDOVASCULAR PACKS
Lot or serial number
531965
Model or catalog number
SCV30DDKG3
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
V. CARDIAC ELECTROPHYSIOLOGY (EP) PACKS
Lot or serial number
497409
523467
524110
529564
534796
556998
Model or catalog number
SCV30EPBGB
SCV30EPMGG
SCV30EPOHG
SCV30EPSHB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
W. PACEMAKER PACKS (ENSEMBLE PACEMAKER)
Lot or serial number
533909
Model or catalog number
SAN30PMUO1
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
X. HAEMODYNAMIC PACKS (ENSEMBLE HEMODYNAMIQUE)
Lot or serial number
523500
527755
Model or catalog number
SAN30CAS10
SAN30HDGM3
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
Y. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE INSERTION PACKS
Lot or serial number
532310
534982
Model or catalog number
SAN30PPEJI
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
Z. TENSION-FREE VAGINAL TAPE (TVT) PACKS
Lot or serial number
514450
Model or catalog number
SMA30TVVI4
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AA. OBSTETRICS AND GYNAECOLOGY (OB/GYN) PACKS
Lot or serial number
521005
525903
Model or catalog number
SMA30MASBE
SMA30MISBD
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AB. ENDOMETRECTOMY PACKS
Lot or serial number
522113
Model or catalog number
SMA30ENVIA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AC. DILATION AND CURETTAGE (D AND C) PACKS
Lot or serial number
531961
533559
535296
Model or catalog number
SMA30DCABF
SMA30DCAHG
SMA30DCJGE
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AD. GENERAL GYNAECOLOGY (GYNE) PACKS
Lot or serial number
497412
527632
528212
539831
540378
559470
Model or catalog number
PB30MJGTD
SMA30GHALC
SMA30MNNTE
SMA30MVCWB
SMA30VLCVH
SMA30VLWOA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AE. TRANSOBTURATOR (TOT) PACKS
Lot or serial number
531945
Model or catalog number
SOT30TVCSB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AF. LOCAL CYSTOSCOPY (CYSTO) PACKS
Lot or serial number
501016
520994
527745
556937
Model or catalog number
SBA30CYCWC
SOT30CYCWB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AG. HARMONIZED MAJOR MINIMALLY INVASIVE SURGERY (MIS) LITHOTOMY PACKS
Lot or serial number
521730
527341
528433
532292
535620
539886
562236
Model or catalog number
SBA30LIBCC
SBA30LIVHJ
SBA30LLCHB
SBA30VLEGG
SMA30LIVHH
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AH. LAPAROSCOPIC SIGMOIDECTOMY (SIGMOIDECTOMIE SCOPIE) PACKS
Lot or serial number
556973
Model or catalog number
SBA30LLPBO
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AI. ANAL SURGERY PACKS (ENSEMBLE CHIRURGIE ANALE)
Lot or serial number
529575
541107
Model or catalog number
SBA30RAOTB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AJ. LAPAROSCOPIC ANTERIOR RESECTION (RESECTION ANTERIEURE SCOPIE) PACKS
Lot or serial number
519678
519744
524142
529604
531941
565535
Model or catalog number
SBA30ABDLF
SBA30RBLSG
SBA30RBRRC
SBA30REGMH
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AK. ROBOTIC SURGERY (CHIRURGIE ROBOTIQUE) PACKS
Lot or serial number
534978
551200
Model or catalog number
PG30MCGTE
SBA30RBJGQ
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES
AL. PERI GYNECO 3 PACK
Lot or serial number
522970
Model or catalog number
SMA30PGCFC
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
UNITED STATES