EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration recall: Sterility Concern
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Why was EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration recalled?
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
- Product
- EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
- Recalling firm
- Bard Peripheral Vascular Inc
- 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
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)