Intraosseous Powered Drive and Needle Kits
Brand(s)
Summary
Quarantine/ destroy affected inventory, share recall notice with users, return completed response form.
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 |
Needle Kit For Powered Driver |
More than 10 numbers, contact manufacturer. |
D015451NK |
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
Bard Access Systems, Inc.
605 North 5600 West, Salt Lake City, Utah, United States, 84116
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