Health product recall

Needle Kit For Powered Driver

Last updated

Summary

Product
Needle Kit For Powered Driver
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected 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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Bard Access Systems, Inc.

605 North 5600 West, Salt Lake City, Utah, United States, 84116

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
Identification number
RA-82427

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