Z-2248-2021 Class II Ongoing
FDA device recall Z-2248-2021 was initiated by Bard Peripheral Vascular Inc on June 23, 2021 and is designated Class II. Reason for recall: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. The recall status is ongoing. Affected quantity: 560 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 23, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560 devices
Product Description
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Reason for Recall
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Distribution Pattern
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
Code Information
Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;