Z-0153-2022Class II

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X...

Name: Z-0153-2022 Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X...
Creator: Bard Peripheral Vascular Inc
Published: 2021-08-24
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2021-08-24 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable... on 2021-08-24. FDA classified it as Class II and gives the reason as "Due to misbranded products shipped to customers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0153-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-24
Posted: 2021-10-19
Terminated: 2024-12-23
Recalling firm: Bard Peripheral Vascular Inc
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
Product code: KNW Instrument, Biopsy
Reason for recall: Due to misbranded products shipped to customers.
Root cause tag: manufacturing process
FDA root 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: [email protected] 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
Product codes and lots: Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0153-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19
Z-0154-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code KNW

K171531Class IIJamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleCare Fusion / cleared 2017-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)