Recall Z-2248-2021— Bard Peripheral Vascular Inc

Name: FDA recall Z-2248-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-23

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2021-06-23. It names one FDA 510(k) clearance: K171531. Product: EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm. Reason: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-06-23
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 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 NeedleCare Fusion·cleared 2017-09-11

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

EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm

Reason for recall

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.