Coloplast Catheters
Brand(s)
Last updated
Summary
Product
Coloplast Catheters
Issue
Medical devices - Labelling and packaging
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Prostatic Catheters | More than 10 numbers, contact manufacturer. | XB6322 XB6L22 XB6L24 |
| Folysil Catheters | More than 10 numbers, contact manufacturer. | AA6316 AA6314 AA6310 AA6322 AA6324 AA6308 AA6318 AA6320 AA6312 |
| Prostatic Catheters | More than 10 numbers, contact manufacturer. | AB6G20 AB6020 AB6320 AB6A18 AB6A22 AB6C24 AB6G24 AB6324 AB6G18 AB6H22 AB6520 AB6B24 AB6C18 AB6C22 AB6A20 AB6220 AB6318 AB6A24 AB6018 AB6022 AB6224 AB6322 AB6120 AB6122 AB6222 AB6518 AB6C20 AB6G22 AB6H18 AB6H24 |
| Folysil Catheters | More than 10 numbers, contact manufacturer. | AA6120 AA6412 AA6420 AA6110 AA6114 AA6124 AA6406 AA6C22 AA6106 AA6410 AA6514 AA6516 AA6408 AA6512 AA6112 AA6118 AA6418 AA6422 AA6C20 AA6108 AA6122 AA6414 AA6116 AA6416 AA6522 AA6C18 AA6C24 |
Issue
This recall is due to breach in sterility barrier (packaging pouch). The products involved with a sterilization issue was tested to evaluate impact to package integrity (blue-dye penetration test). Pouch integrity failures were observed due to holes in the pouch. This defect is not easily visible by the product's users.
Recall start date: December 2, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Companies
| Coloplast A/S |
| Holtedam 1, Humlebaek, Denmark, 3050 |
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76769
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