Data Foundry

Medical device recalls 2021

Catalog # BEK3411 — Class II medical device recall Z-0154-2022

Terminated recall by Bard Peripheral Vascular Inc, reported 2021-10-27, distributed in CA, GA, HI, IL, IN, LA, MO, MS…. Due to misbranded products shipped to customers.

Recall numberZ-0154-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2021-08-24
Classified2021-10-19
Reported by FDA2021-10-27
Terminated2024-12-23
DistributedCA, GA, HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, WA
Quantity360 devices
Reason classeslabeling
UPC / GTIN / UDI-DI50885403057258
Lot numbers0001378561, BEK3411
Serial numbers0001378561
Model numbersBEK3411
Expiration dates2021-12-31

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 for recall

Due to misbranded products shipped to customers.

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-0154-2022. 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.