Class 2 Device Recall Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray

• Date Initiated by Firm: August 24, 2021
• Create Date: October 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0153-2022
• Recall Event ID: 88674
• 510(K)Number: K171531
• Product Classification: Instrument, biopsy - Product Code KNW
• Product: Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion.; ; Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique
• Code Information: Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: Padraic OBrien ; 480-597-8203
• Manufacturer Reason for Recall: Due to misbranded products shipped to customers.
• FDA Determined Cause: Process control
• Action: On September 15, 2021, the firm, BD, sent out an "URGENT MEDICAL DEVICE CORRECTION" letter to their customers and Distributors via FedEx, informing them of the two products, first product or kit had missing component and the second product had extra component of the first product. The firm asked customers/Distributors to take the actions as: 1)Please check all inventory locations within your institution for the product listed in Table A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facilitys destruction process.2.) Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction.3.) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution.4.) Complete and return the attached Customer Response Form to BD Post Market Quality at Email: BDRC20@bd.com or Fax No.: 312-949-0410 confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process your credit. 5.) Please contact your BD representative to assist in this process or you may also contact the number below for further assistance. 6) Issue credit to customers following receipt of the completed customer response form. 7) Firm initiated actions to prevent recurrence of this product issue. The firm asked customers to report any adverse health consequences experienced with the use of this product to the firm and to FDA. The firm provided below contact information as : Contact Information: North American Regional Complaint Center1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT for Recall Questions, Product Complaints, Technical Questions.
• Quantity in Commerce: 360 devices
• Distribution: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KNW and Original Applicant = CareFusion