FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: 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.
- Recall number
- Z-1689-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-03-17
- Posted
- not on file
- Terminated
- 2024-07-15
- Reason
- Sterility compromised due to packaging pouches that may not be sealed properly
- 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 BDRC5@bd.com 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 BDRC5@bd.com 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 0001303256 and 0001303257
- 510(k) numbers
- ["K171531"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28