FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
- Recall number
- Z-2248-2021
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
- Status
- Open, Classified
- Initiated
- 2021-06-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
- Root cause
- Packaging process control
- Action
- On 07/15/2021, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx to customers/distributors informing them that the firm has confirmed a complaint regarding an open packaging seal, breaking the sterile barrier. Customers are instructed to: 1. Please check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facilitys destruction process. 2. Share this notice with any users of the product within their facilities to ensure they are also aware of this Urgent Medical Device Correction. 3. If they purchased this product from a distributor, contact their distributor for further instructions. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process your replacement. 5. Please contact their Recalling Firm's representative to assist in this process or they may also contact the number below for further assistance. The Recalling Firm will: 1. Issue replacements for all customers affected by the recall following receipt of the completed Customer Response Form. 2. taken action to prevent recurrence of this product issue. For questions or assistance contact (Recall Questions/Product Complaints/Technical Questions): North American Regional Complaint Center 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted M-F 8am - 5pm CT
- Quantity
- 560 devices
- Distribution
- U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
- Lot, serial or model codes
- Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
- 510(k) numbers
- ["K171531"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28