Recall MonitorHealth ProductsType I recall
Needle Kit For Powered Driver
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Needle Kit For Powered Driver
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Needle Kit For Powered Driver | BSLC10105 | D015251NK |
| Needle Kit For Powered Driver | BSLC12123 | D015251NK |
| Needle Kit For Powered Driver | BSLC9485 | D015351NK |
| Needle Kit For Powered Driver | BSLC10874 | D015351NK |
| Needle Kit For Powered Driver | BSLC10101 | D015451NK |
| Needle Kit For Powered Driver | BSLC10520 | D015451NK |
| Needle Kit For Powered Driver | BSLC9465 | D015551NK |
| Needle Kit For Powered Driver | BSLC11452 | D015551NK |
Issue
Some lots were manufactured with out-of- tolerance dimensions, and as a result some users have reported difficulty removing the obturator (stylet) following placement of the BD Intraosseous Vascular Access System Needle Sets. Based on complaint reports, bench testing completed by BD and clinical observations, this may occur when pulling back on the drill during the insertion or when failing to pull straight back with the powered driver or incorrectly rotating or trying to unscrew the obturator. These actions allow the rotation and locking of the obturator-needle hub interface for specific lots of the product with out-of-tolerance dimensions.