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" Bo
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling 3,961 Jamshidi bone marrow biopsy and aspiration needles due to complaints about incomplete or open packaging seals that could allow the sterile products to become non-sterile. The affected devices include models TJM6008, TJC3513, TJM4011, TJC4011, TJM4008, and TJC4008, with specific lot numbers and serial numbers identified in the recall notice. The 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, EMEA countries, Japan, Mexico, Saudi Arabia, Singapore, and Taiwan.
The source document does not specify a remedy or recommended action for affected consumers.
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: 3,961 devices Lot/code info: 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;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.