CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report

Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X recalled

Bard Peripheral Vascular is recalling Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X, distributed in 16 states. The recall was initiated on 24 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCat No.: BEK3411; Lot /Serial No.: 0001378561; UDI # BEK3411, Lot BEK3411, Lot BEK3411, Lot 0001378561; (01)50885403057258(17)211231(10)0001378561; Mfg. Date 08/19/2020; Exp. Date: 12/31/2021; Qty: 360

Quantity recalled360 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0154-2022
FDA event ID: 88674
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2021
FDA classified: 19 Oct 2021
Reported: 27 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

24 Aug 2021	Recall initiated by company
19 Oct 2021	Classified by FDA	+56 days
27 Oct 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to misbranded products shipped to customers.

Product as listed by the FDA

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.

Where it was distributed

U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None

California Georgia Hawaii Illinois Indiana Louisiana Missouri Mississippi North Carolina Ohio Pennsylvania Puerto Rico Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

Due to misbranded products shipped to customers.

Which lots are affected?

Cat No.: BEK3411; Lot /Serial No.: 0001378561; UDI # BEK3411, Lot BEK3411, Lot BEK3411, Lot 0001378561; (01)50885403057258(17)211231(10)0001378561; Mfg. Date 08/19/2020; Exp. Date: 12/31/2021; Qty: 360

Where was it sold?

U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88674

This product is part of a recall event; the main page for the event is Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy recalled.

Reported	Class	Recall	Company	Reason	Where
27 Oct 2021	CLASS II	Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy recalled	Bard Peripheral Vascular	Labeling Errors	16 states

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