—#189256

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

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171531
Affected lot / code info: Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055;

Why it was recalled

Due to misbranded products shipped to customers.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None

Timeline

Recall initiated: 2021-08-24
Terminated: 2024-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.