# FDA recall Z-1397-2022

> **Bard Access Systems, Inc.** · Class I · device recall initiated 2022-06-20.

## Product

Intraosseous needle and driver.     Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga,   D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga,  D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga,  D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga,  D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga,  D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga,  D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga,  D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga,  D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga,  D015551MK/ BD Manual Driver Needle Kit 55mm x 15G,  D001001/ BD Intraosseous Powered Driver (drill)

## Reason for recall

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

## Distribution

Distribution US nationwide and Canada.

## Key facts

- **Recall number:** Z-1397-2022
- **Recalling firm:** Bard Access Systems, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-20
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1397-2022

## Citation

> AI Analytics. FDA recall Z-1397-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1397-2022. Source: US FDA. Licensed CC0.

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