Class 2 Device Recall Jamshidi Bone Marrow Biopsy/Aspiration Needle

• Date Initiated by Firm: March 17, 2020
• Create Date: April 09, 2020
• Recall Status: Terminated on July 15, 2024
• Recall Number: Z-1689-2020
• Recall Event ID: 85338
• 510(K)Number: K171531
• Product Classification: Instrument, biopsy - Product Code KNW
• 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.
• Code Information: Lot Numbers: 0001303256 and 0001303257
• FEI Number: 2020394
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: SAME; 480-303-2602
• Manufacturer Reason for Recall: Sterility compromised due to packaging pouches that may not be sealed properly
• FDA Determined 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 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNW