—#180558

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171531
Affected lot / code info: Lot Numbers: 0001303256 and 0001303257

Why it was recalled

Sterility compromised due to packaging pouches that may not be sealed properly

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-03-17
Terminated: 2024-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180558. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.