Recall Z-0154-2022— Bard Peripheral Vascular Inc
Class II · Terminated
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2021-08-24, terminated 2024-12-23. It names 2 FDA 510(k) clearances: K171531, K913306. Product: Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.. Reason: Due to misbranded products shipped to customers..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-24
- Terminated
- 2024-12-23
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
2 on FDA's record- K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
- K913306 — BONE-TEMNO/STERNUM-TEMNO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
Reason for recall
Due to misbranded products shipped to customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.