Agency classClass IIOur severity:High FDA (Devices)·Z-0153-2022·Announced 2021-10-27

Jamshidi Bone Marrow Biopsy Tray Recalled for Misbranding

Bard Peripheral Vascular Inc is recalling an Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray due to misbranding. A total of 360 devices were distributed to healthcare facilities across multiple U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall due to misbranding of a bone marrow biopsy device. Misbranding of medical devices used in invasive procedures presents risk of harm from incorrect labeling or instructions for use, meeting the rubric criterion for high-risk products even without reported injuries.

Plain-English summary

Bard Peripheral Vascular Inc is recalling the Economy Jamshidi Bone Marrow Biopsy and Aspiration Tray (Catalog # BEK4511) due to misbranding of the distributed products. The product is designed for bone marrow biopsy and aspiration procedures on the posterior iliac crest and includes an 11 gauge 4-inch biopsy/aspiration needle and a 15 gauge adjustable aspiration needle.

Approximately 360 devices were distributed in quantities of 10 per tray to healthcare facilities in California, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, and Washington.

Patients who have had or are scheduled for bone marrow biopsy or aspiration procedures should contact their healthcare provider to determine if they received this product and for guidance on any necessary next steps.

The recalled product

Product: Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion.…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Surgical / Biopsy
Hazard: mis-labeling
Affected units: 360

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Cat No.: BEK4511
Lot /Serial No.: 0001379055
UDI # (01)50885403057265(17)211231(10)0001379055

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Bard Peripheral Vascular Inc

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