Z-1689-2020Class II

Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile -

Name: Z-1689-2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile -
Creator: Bard Peripheral Vascular Inc
Published: 2020-03-17
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2020-03-17 / Terminated / root cause: packaging

FDA source

Bard Peripheral Vascular Inc began a recall of Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an... on 2020-03-17. FDA classified it as Class II and gives the reason as "Sterility compromised due to packaging pouches that may not be sealed properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1689-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-17
Posted: 2020-04-09
Terminated: 2024-07-15
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: KNW Instrument, Biopsy
Reason for recall: Sterility compromised due to packaging pouches that may not be sealed properly
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Becton, Dickinson and Company (BD) issued notification on 3/17/20 stating reason for recall, health risk, and action to take: check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, immediately contact that location, advise them of the recall, forward these instructions and have them complete the instructions within this recall notice. 3. Please remove any identified product from your shelves. 4. Destroy all identified product from the affected product code / lot number combinations following your institutions process for destruction. 5. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating that you do not have affected product in inventory. Once the product affected by this recall has been removed from your inventory and destroyed: 6. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you destroyed. It is extremely important that we receive this information. 7. Email the completed Recall and Effectiveness Check Form to BD Regulatory Compliance at [email protected] or fax it to 312-949-0229. 8. Once the Recall and Effectiveness Check Form has been completed and emailed to BD Regulatory Compliance at [email protected] or faxed to 312-949-0229 and all information has been verified, BD will issue you a product replacement for any destroyed inventory. Please call our BD Customer/Technical Support at 800-638-8663 with any questions.
Quantity in commerce: 8,170 units (US: 420 and OUS: 7,750)
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.
Product codes and lots: Lot Numbers: 0001303256 and 0001303257

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-09

Product code KNW

K171531Class IIJamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleCare Fusion / cleared 2017-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)