PlainRecalls
FDA Devices Moderate Class II Terminated

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. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Reported: October 27, 2021 Initiated: August 24, 2021 #Z-0153-2022

Product Description

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. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Reason for Recall

Due to misbranded products shipped to customers.

Details

Units Affected
360 devices
Distribution
U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
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. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique. Recalled by Bard Peripheral Vascular Inc. Units affected: 360 devices.
Why was this product recalled?
Due to misbranded products shipped to customers.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0153-2022.