This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Recalled products by Cardinal Health (part 1)

Starting date:
October 16, 2012
Posting date:
November 26, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15898

Recalled Products

  1. Cataract Pack
  2. Knee Pack
  3. Hip Pack
  4. Pacemaker Pack
  5. Phaco Pack
  6. Orthopaedic Pack
  7. Urology Pack
  8. General Surgery Pack
  9. Extremity Pack
  10. Eye Pack
  11. Cataract Pack
  12. Plastics Kit
  13. Knee Pack
  14. Delivery Pack
  15. Shoulder Pack
  16. Prostatectomy Pack
  17. Craniotomy Pack
  18. Spinal Pack
  19. Laparoscopy Packs
  20. C-Section Pack
  21. Pack Mammaire
  22. Lap Pack
  23. Vascular Pack
  24. Thoracic  Pack
  25. Aorta/Aneurysm Pack
  26. Open Heart Bypass Pack

Reason

Some presource packs, kits and modules may not contain the temperature storage statement advising to store product at room temperature (15-30) on the product labelling.  The missing temperature and storage information relates to the drugs in the kits and poses no threat or safety issue for the customer.  All manufactured product has been stored appropriately during and after manufacture and distribution.

Affected products

A. Cataract Pack

Lot or serial number

116088, 116652, 116996, 117330

Model or catalog number

SEY30CACOE, SEY30CAPGB, SEY30CASBF, SEY30CTPBC

Companies
Manufacturer

Cardinal Health



B. Knee Pack

Lot or serial number

116734, 116736, 116904

Model or catalog number

SOP30ARLAC, SOP30TKTEL, SOP30TKYKH

Companies
Manufacturer

Cardinal Health



C. Hip Pack

Lot or serial number

116738, 117059, 117628, 117754

Model or catalog number

SOP30FHJTF, SOP30HPRGH, SOP30HPSTD, SOP30PHPBC

Companies
Manufacturer

Cardinal Health



D. Pacemaker Pack

Lot or serial number

116963, 116982, 117513

Model or catalog number

SAN30LIKGB, SAN30PAVHE, SCV30PCKGG

Companies
Manufacturer

Cardinal Health



E. Phaco Pack

Lot or serial number

116888

Model or catalog number

MEY30PICEA

Companies
Manufacturer

Cardinal Health



F. Orthopaedic Pack

Lot or serial number

117362

Model or catalog number

SOP30OPMKJ

Companies
Manufacturer

Cardinal Health



G. Urology Pack

Lot or serial number

116086, 117945

Model or catalog number

SBA30URSBD, SOT30MJSM1

Companies
Manufacturer

Cardinal Health



H. General Surgery Pack

Lot or serial number

116533, 117013, 118107, 118339

Model or catalog number

SBA30THGMC, SBA30THHSA, SBA30THSMB, SBA30UPCHB

Companies
Manufacturer

Cardinal Health



I. Extremity Pack

Lot or serial number

SOP30AHCBE, SOP30LCPBC

Model or catalog number

SOP30AHCBE, SOP30LCPBC

Companies
Manufacturer

Cardinal Health



J. Eye Pack

Lot or serial number

118344

Model or catalog number

MEY30BLWGB

Companies
Manufacturer

Cardinal Health



K. Cataract Pack

Lot or serial number

116667

Model or catalog number

SEY30CAVGC

Companies
Manufacturer

Cardinal Health



L. Plastics Kit

Lot or serial number

116012

Model or catalog number

PW30PLPM2

Companies
Manufacturer

Cardinal Health



M. Knee Pack

Lot or serial number

116972, 117892

Model or catalog number

SOP30KNUHS, SOP30TKTTB

Companies
Manufacturer

Cardinal Health



N. Delivery Pack

Lot or serial number

117441

Model or catalog number

SMA30DLCLD

Companies
Manufacturer

Cardinal Health



O. Shoulder Pack

Lot or serial number

116898

Model or catalog number

SOP30SHNLC

Companies
Manufacturer

Cardinal Health



P. Prostatectomy Pack

Lot or serial number

117616, 117766

Model or catalog number

SOT30PRGBA, SOT30PRRRD

Companies
Manufacturer

Cardinal Health



Q. Craniotomy Pack

Lot or serial number

116751

Model or catalog number

SNE30CRVGH

Companies
Manufacturer

Cardinal Health



R. Spinal Pack

Lot or serial number

116910, 117758

Model or catalog number

SBA30SPGHA, SNE30BPQEF

Companies
Manufacturer

Cardinal Health



S. Laparoscopy Packs

Lot or serial number

117608

Model or catalog number

SMA30LPMKH

Companies
Manufacturer

Cardinal Health



T. C-Section Pack

Lot or serial number

116746, 116809, 116864, 116965, 117913, 118266

Model or catalog number

SMA30CCKGI, SMA30CCWRB, SMA30CSBUD, SMA30CSHCA, SMA30CSHMC, SMA30CSOGM

Companies
Manufacturer

Cardinal Health



U. Pack Mammaire

Lot or serial number

116590

Model or catalog number

SBA30MMDLF

Companies
Manufacturer

Cardinal Health



V. Lap Pack

Lot or serial number

116753, 116828, 117050

Model or catalog number

SBA30LPSA1, SLC30LCGHB, SLC30LCSYB

Companies
Manufacturer

Cardinal Health



W. Vascular Pack

Lot or serial number

116790

Model or catalog number

SCV30VARHF

Companies
Manufacturer

Cardinal Health



X. Thoracic  Pack

Lot or serial number

116768

Model or catalog number

SCV30THHDD

Companies
Manufacturer

Cardinal Health



Y. Aorta/Aneurysm Pack

Lot or serial number

116817

Model or catalog number

SBA30AAVHF

Companies
Manufacturer

Cardinal Health



Z. Open Heart Bypass Pack

Lot or serial number

116860

Model or catalog number

SCV30OHSMX

Companies
Manufacturer

Cardinal Health