TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with… — Class II medical device recall Z-2247-2021
Ongoing recall by Bard Peripheral Vascular Inc, reported 2021-08-18, distributed nationwide. Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-steril
| Recall number | Z-2247-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2021-06-23 |
| Classified | 2021-08-11 |
| Reported by FDA | 2021-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CN, JP, MX, SA, SG, TW |
| Quantity | 3,961 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10885403044038, 10885403044052, 10885403044564, 10885403044588, 10885403044595 |
| Serial numbers | 0001330400, 0001330707, 0001331230, 0001331232, 0001334951 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2247-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.