Z-2247-2021 Class II Ongoing
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
- 3,961 devices
Product Description
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" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G 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: 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;