FDA Device recall Z-1689-2020
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The devic…
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The devic… by Bard Peripheral Vascular, citing sterility compromised due to packaging pouches that may not be sealed properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-17 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
Reason
Sterility compromised due to packaging pouches that may not be sealed properly
Identifiers
| code_info | Lot Numbers: 0001303256 and 0001303257 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2020%22
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