Recall MonitorHealth Products
Med-RX Wound Care Kits
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Med-RX Wound Care Kits
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.