Recall MonitorHealth Products
CTP - Tubing sets
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - General hospital and personal use
Product: CTP - Tubing sets
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 |
|---|---|---|
| Cabaret 25 Kg | 3000419748 | BO-HQV 59206 |
| Perfusion Pack | 3000407529 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000415791 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000460078 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000491063 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000468700 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000460082 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000407530 | BEQ-HQV 52700-1 |
| Perfusion Pack | 3000491064 | BEQ-HQV 52700-1 |
| HL Pack With HL 20 | More than 10 numbers, contact manufacturer. | BEQ-HQV 46904 |
| OHI Perfusion Pack | More than 10 numbers, contact manufacturer. | BO-HQV 55004 |
Issue
The manufacturer became aware of this issue due to six customer complaint reports. It was found that the sterile barrier was compromised, as the Tyvek lid was found opened prior to use. No harm to any person was reported. An internal investigation has confirmed that all affected products show a consistent similar defect pattern occurring at the same sealing area and were manufactured using the same tool. Therefore, this FSCA is limited to all sterile products within shelf-life manufactured using the same tool. Consignees will be asked to confirm receipt of the field action notification. Consignees will be asked to return all unused, affected sold product from consignee locations.