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U.S. Department of Health and Human Services

Class 2 Device Recall CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC

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  Class 2 Device Recall CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC see related information
Date Initiated by Firm August 01, 2019
Create Date August 28, 2019
Recall Status1 Terminated 3 on May 06, 2020
Recall Number Z-2411-2019
Recall Event ID 83537
510(K)Number K171531  
Product Classification Instrument, biopsy - Product Code KNW
Product 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC
Catalog Number: TMJ4008
Code Information Lot Number: 0001159474 Exp. Date: 2022-08-31 UDI: (01)10885403044564 + (10)0001159474(17)220831
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
201-847-6800
Manufacturer Reason
for Recall		 Product Pouches may not be sealed properly and compromise the sterility of the device
FDA Determined
Cause 2		 Packaging process control
Action BD notified US consignees via FedEx August 1, 2019,and contacted via email. Sub recall requested and BD will notify customers. BD is requesting that customers destroy product at their location. The kit packer asked to return product. BD will mail additional communications to the kit customers. A business response form is included with the letter to assist direct consignees in responding to the field action. Questions contact BD Customer/Technical Support 800-638-8663 Monday  Friday between 7:00am and 7:00pm (EST) in the United States.
Quantity in Commerce 700 units
Distribution CA, IL Foreign: Taiwan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = CareFusion
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