Health product recall

Cardinal Health/Ecolab equipment drapes, table cover, and surgical room turnover (SRT) kits

Brand(s)
Last updated

Summary

Product
Cardinal Health/Ecolab equipment drapes, table cover, and surgical room turnover (SRT) kits
Issue
Medical devices - Sterility Issue
What to do

Review notice and forward to users, quarantine any affected inventory, complete/return response form. 

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalog number
ORIF Wrist Sturgeon Pack 929766 SOP30ACSCG
Pack Trauma Upper Extremity 969776 SOP30UPOHD
RHS Pacemaker 9591 SCV30PMRGA
Thoracic Pack 919439 SCV30THLHA
Anterior Total Hip Pack 924124 SOP30HALHB
Foot Ankle Set 3 16244 SOP30AKJTF
Kit, Tavi 898892 PV30VPUHA
Fracture Pack 986684 SOP30FRUHE
Hip Scope Pack 12487 SOP30HSCHE
Femoral Angioplasty 16600 SAN30ANTHD
Ortho Split Pack 921913 SOP30OSVI8
Hip Pack 991876 SOP30HPWME
Percutaneous Nephrolithotomy (PERC) Packs 54914 SOT30PCHSC
Vancouver General Hospital (VGH) Pacemaker Pack 922151 SAN30PPVGA
Foothills Medical Centre (FMC) Liver Resection Pack 937398 SBA30MJCHH
Percutaneous Nephrolothomy (PCNL) Packs 987163 919471 SOT30PENBB SOT30PELCA
Endovascular Aneurysm Repair (EVAR) Kits 38772 SCV30EVTHE

Issue

Cardinal Health Canada has been notified of an urgent product recall initiated by Ecolab for the equipment drapes, table cover, and surgical room turnover (SRT) kits. Ecolab as Microtek has received odor complaints on certain lots. The odor has been traced back to one specific shipping container used to transport the above products and lots to Ecolab's distribution center. Analysis indicates that the source of the odor is naphthalene. Presource® has completed its investigation regarding this recall and determined that we have distributed Presource kits containing the affected Ecolab component(s) and lot number(s).

Recall start date: August 17, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Orthopaedics
Companies

Cardinal Health

3651 Birchwood Drive, Waukegan, Illinois, United States, 60085

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type I
Identification number
RA-74188

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