Device product
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Z-2248-2021
Product summary
- Event
- Event 88314
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 560 devices
- Official record key
device-enforcement:Z-2248-2021
Official wording
Reason: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Code information: Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
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
Derived failure modes
-
Labeling or packaging
open packaging