RecallRadar

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…

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

AgencyFDA Device
Recall numberZ-1689-2020
ClassificationClass II
Statusterminated
Initiated2020-03-17
Published2020-04-15
Last updated2026-09-13 11:55 UTC
CompanyBard Peripheral Vascular
DistributionUS

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_infoLot 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.