Coloplast Catheters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Prostatic Catheters |
More than 10 numbers, contact manufacturer. |
XB6322 |
Folysil Catheters |
More than 10 numbers, contact manufacturer. |
AA6316 |
Prostatic Catheters |
More than 10 numbers, contact manufacturer. |
AB6G20 |
Folysil Catheters |
More than 10 numbers, contact manufacturer. |
AA6120 |
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
| Coloplast A/S |
| Holtedam 1, Humlebaek, Denmark, 3050 |
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