EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling 560 units of the EJM4011 Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle (11G x 10cm) due to complaints about incomplete or open packaging seals that could allow the product to become non-sterile. The affected devices were distributed nationwide across 12 U.S. states (Arizona, Connecticut, DC, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas, and Virginia) as well as internationally to Australia, Belgium, China, countries in the EMEA region, Japan, Mexico, Saudi Arabia, Singapore, and Taiwan.
The recalled devices are identified by catalog number EJM4011 with UDI (01)10885403464157(17)241031(10)0001330769, and include serial numbers 0001330769 and 0001331231. The recall record does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Reason for recall: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. 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 Quantity: 560 devices Lot/code info: Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769; Serial Numbers: 0001330769; 0001331231;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.