Recall MonitorHealth Products
CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation 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 | Model or catalogue number | Lot or serial number |
|---|---|---|
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558700 | More than 10 numbers, contact manufacturer. |
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558670 | More than 10 numbers, contact manufacturer. |
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558680 | More than 10 numbers, contact manufacturer. |
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558710 | More than 10 numbers, contact manufacturer. |
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558690 | More than 10 numbers, contact manufacturer. |
| CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter | M00558660 | More than 10 numbers, contact manufacturer. |
Issue
Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.