FDAClass IIApril 15, 2020

Jamshidi Bone Marrow Biopsy/Aspiration Needle recall: Sterility Concern

Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is…

Why was Jamshidi Bone Marrow Biopsy/Aspiration Needle recalled?

Sterility compromised due to packaging pouches that may not be sealed properly

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 0001303256 and 0001303257

Product
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is…
Recalling firm
Bard Peripheral Vascular Inc
Quantity
8,170 units (US: 420 and OUS: 7,750)
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls