Recall MonitorHealth Products
TufTex® Embolectomy and Pruitt® Occlusion Catheters
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: TufTex® Embolectomy and Pruitt® Occlusion Catheters
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 catalog number |
|---|---|---|
| TufTex® 5F Plus Over-The-Wire Embolectomy Catheter | More than 10 numbers, contact manufacturer. | E1651-84 E1651-88 |
| Pruitt® Occlusion Catheter | More than 10 numbers, contact manufacturer. | 2103-36 2103-46 2103-56 |
| Pruitt® Irrigation Occlusion Catheter | More than 10 numbers, contact manufacturer. | 2102-09 |
| TufTex® Over-The-Wire Embolectomy Catheter | More than 10 numbers, contact manufacturer. | 1651-44 E1651-34 1651-38 E1651-38 E1651-44 1651-64 E1651-64 E1651-68 1651-34 E1651-48 E1651-78 |
Issue
During internal product testing, we observed some packages to have incomplete seals (sterile barrier). If the sterile barrier of the packaged device is broken, there is a risk of contamination of the device and subsequent risk of infection if used. Recall start date: April 10, 2025