Health product recall

Intraosseous Powered Drive and Needle Kits

Last updated

Summary

Product
Intraosseous Powered Drive and Needle Kits
Issue
Medical devices - Performance issue
What to do

Quarantine/ destroy affected inventory, share recall notice with users, return completed response form. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Intraosseous Powered Driver More than 10 numbers, contact manufacturer. D001001
Manual Driver Needle Kit More than 10 numbers, contact manufacturer. D015351MK D015451MK D015151MK D015551MK D015251MK
Needle Kit For Powered Driver More than 10 numbers, contact manufacturer. D015451NK D015251NK D015551NK D015351NK D015151NK

Issue

1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access. 2. Needle safety mechanism may not deploy as the stylet is removed from the intraosseous needle post placement. 3. Metal discs sticking in power driver, rendering the driver unable to be used

Recall start date: June 20, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
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 II
Identification number
RA-64317

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