CanadaThe Needle Kit for Powered Driver (Bard Access Systems) with catalogue numbers D015251NK, D015351NK, D015451NK and D015551NK and lot numbers BSLC10105, BSLC12123, BSLC9485, BSLC10874, BSLC10101, BSLC10520, BSLC9465 and BSLC11452 is affected. Some lots were manufactured with out-of-tolerance dimensions causing difficulty removing the obturator (stylet) after placement when pulling back on the drill, pulling off-axis, rotating, or trying to unscrew the obturator. Contact the manufacturer for additional information.
What's being recalled
Companies: Bard Access Systems, Inc., 605 North 5600 West, Salt Lake City, Utah, United States, 84116.
How to identify it
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC10105; Model or catalogue number: D015251NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC12123; Model or catalogue number: D015251NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC9485; Model or catalogue number: D015351NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC10874; Model or catalogue number: D015351NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC10101; Model or catalogue number: D015451NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC10520; Model or catalogue number: D015451NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC9465; Model or catalogue number: D015551NK
Affected products: Needle Kit For Powered Driver; Lot or serial number: BSLC11452; Model or catalogue number: D015551NK
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States