Recall MonitorHealth Products
BD Texium™ Components
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: BD Texium™ Components
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| BD Texium™ Closed Male Luer With Female Cap | More than 10 numbers, contact manufacturer. | 10012241-0500 |
| BD 20 Drop Secondary Set And BD 31-In Sec Set 20dp | More than 10 numbers, contact manufacturer. | 10013364T 70001B-07T |
| Alaris™ Pump Infusion Set SmartSite Bag Access Non-Vented Bonded Texiumtm With Priming Cap Back Check Valve 2 Smartsitetm Ysites | More than 10 numbers, contact manufacturer. | 10013361T |
Issue
Through complaint investigations, BD has identified that specific lots of standalone Texium™ components, and IV infusion sets and syringes containing the Texium™ closed-male luer component (as listed in attachment 1) have the potential to leak during use at the connection interface between the Texium™ component and the SmartSite™ needle-free connector. BD has confirmed that this issue is limited to the affected products listed in attachment 1. Recall start date: May 12, 2025