This page has been archived on the Web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.

Archived

This page has been archived on the Web.

Health product recall

Recalled Products by Cardinal Health (part 2)

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-15905

Recalled Products

  1. Catheterization Pack
  2. Valve Pack
  3. Minor Surgery Packs
  4. Major Surgery Packs
  5. Abdominoplasty Pack
  6. Breast Reduction Pack
  7. Breast Biopsy Pack
  8. Cholecystectomy Pack
  9. Spinal Pack
  10. Total Hip Pack
  11. Knee Prothesis Pack
  12. Minor Ortho Pack
  13. Shoulder Arthroscopy Pack
  14. Ens. Strl pour Chirugie Nasale
  15. C-Section Pack
  16. Pack Gyne Laparoscopy
  17. Breast Pack
  18. Hand Pack with Chloraprep
  19. Hip Pack
  20. Joint 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. Catheterization Pack

Lot or serial number

117927

Model or catalog number

SAN30CADGI

Companies
Manufacturer

Cardinal Health



B. Valve Pack

Lot or serial number

SCV30VASBF, SCV30VDHMB

Model or catalog number

SCV30VASBF, SCV30VDHMB

Companies
Manufacturer

Cardinal Health



C. Minor Surgery Packs

Lot or serial number

117625

Model or catalog number

SBA30MAWRF

Companies
Manufacturer

Cardinal Health



D. Major Surgery Packs

Lot or serial number

116668, 117032, 117377

Model or catalog number

PD30LTTGG, SBA30MJCVM, SBA30MJROC

Companies
Manufacturer

Cardinal Health



E. Abdominoplasty Pack

Lot or serial number

116824

Model or catalog number

SBA30APSPD

Companies
Manufacturer

Cardinal Health



F. Breast Reduction Pack

Lot or serial number

117175

Model or catalog number

SBA30BRWCL

Companies
Manufacturer

Cardinal Health



G. Breast Biopsy Pack

Lot or serial number

116680

Model or catalog number

SBA30BBNOB

Companies
Manufacturer

Cardinal Health



H. Cholecystectomy Pack

Lot or serial number

SLC30CLALF

Model or catalog number

SLC30CLALF

Companies
Manufacturer

Cardinal Health



I. Spinal Pack

Lot or serial number

117860

Model or catalog number

SNE30SPCLC

Companies
Manufacturer

Cardinal Health



J. Total Hip Pack

Lot or serial number

116638, 116800

Model or catalog number

SOP30THGHF, SOP30THTTB

Companies
Manufacturer

Cardinal Health



K. Knee Prothesis Pack

Lot or serial number

116728, 116995, 117322

Model or catalog number

SOP30PGALD, SOP30PGDLN, SOP30PGIAB

Companies
Manufacturer

Cardinal Health



L. Minor Ortho Pack

Model or catalog number

SOP30MNLSC

Companies
Manufacturer

Cardinal Health



M. Shoulder Arthroscopy Pack

Lot or serial number

117686

Model or catalog number

SOP30SHVRF

Companies
Manufacturer

Cardinal Health



N. Ens. Strl pour Chirugie Nasale

Lot or serial number

117583

Model or catalog number

SEN30NAEUB

Companies
Manufacturer

Cardinal Health



O. C-Section Pack

Lot or serial number

116724, 117425

Model or catalog number

SMA30CSDLL, SMA30CSMKP

Companies
Manufacturer

Cardinal Health



P. Pack Gyne Laparoscopy

Lot or serial number

116821

Model or catalog number

SMA30GLHSI

Companies
Manufacturer

Cardinal Health



Q. Breast Pack

Lot or serial number

117631

Model or catalog number

SOP30PBWRG

Companies
Manufacturer

Cardinal Health



R. Hand Pack with Chloraprep

Lot or serial number

116526

Model or catalog number

SOP30PHWRH

Companies
Manufacturer

Cardinal Health



S. Hip Pack

Lot or serial number

116807

Model or catalog number

SOP30HPJSK

Companies
Manufacturer

Cardinal Health



T. Joint Pack

Lot or serial number

117008, 118164

Model or catalog number

SOP30TJNBD, SOP30TOKGN

Companies
Manufacturer

Cardinal Health


Date modified: