Health product recall

Med-RX Wound Care Kits

Last updated

Summary

Product
Med-RX Wound Care Kits
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Med-RX Wound Care Kits 204016 85-2821
Med-RX Wound Care Kits 212327 85-2821
Med-RX Wound Care Kits 211059 85-2821
Med-RX Wound Care Kits 210981 85-2821
Med-RX Wound Care Kits 201658 85-4149
Med-RX Wound Care Kits 201657 85-4149

Issue

Affected lots of BD Chloraprep™ 1 ml applicator (clear) used in CHS Ltd.'s Med-RX wound care kit may exhibit an open/incomplete seal on packaging of the applicator. If an affected BD product with a compromised sterile barrier is used, the applicator may have been exposed to microbial contamination. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin/soft tissue infection. Less commonly, systemic infection or other infectious complications may occur. In rare cases, particularly in critically ill, immunocompromised or otherwise medically vulnerable patients, severe infection could be life-threatening.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Canadian Hospital Specialties Ltd. Doing Business As CHS
2760 Brighton Road, Oakville, Ontario, Canada, L6H 5T4
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82441

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