Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle,
Summary
The FDA issued a Class II for Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration T by Bard Peripheral Vascular Inc. Reason: Due to misbranded products shipped to customers..
Details
Source
Device Recall
External ID
Z-0153-2022
Action Date
2021-10-27
Status
Terminated
Category
device
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
Lot/Code Info: Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055;
Quantity Affected: 360 devices
Reason for Recall
Due to misbranded products shipped to customers.
Distribution
U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-24
Company
Tempe, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Peripheral Vascular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bard Peripheral Vascular Inc have FDA actions?
Bard Peripheral Vascular Inc has 42 FDA actions in our database, including 33 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0153-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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