Jamshidi recallZ-2247-2021 · Bard Peripheral Vascular Inc · initiated Jun 23, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
FDA root cause category: Packaging process control
What the company is doing
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
Recall details
- Recall number
- Z-2247-2021
- Status
- Open, Classified
- Initiated by the company
- Jun 23, 2021
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 3,961 devices
- Product code
- KNW
- FDA submissions
- K171531
- 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
Product description
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;
Code information (models, lots, serial numbers)
Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951; Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951;
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Jamshidi TJM4008Carefusion 2200, Inc · INSTRUMENT, BIOPSY2 recalls1 report
- Jamshidi TJC4011Carefusion 2200, Inc · INSTRUMENT, BIOPSY1 recall8 reports
- Jamshidi TJM4011Carefusion 2200, Inc · INSTRUMENT, BIOPSY1 recall6 reports
- Jamshidi TJC4008Carefusion 2200, Inc · INSTRUMENT, BIOPSY1 recall1 report
- Jamshidi TJM6008Carefusion 2200, Inc · INSTRUMENT, BIOPSY1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 88314).
- Z-2248-2021 · Open, ClassifiedEJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
- Z-2249-2021 · Open, ClassifiedTIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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