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U.S. Department of Health and Human Services

Class 2 Device Recall Bone marrow needle

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  Class 2 Device Recall Bone marrow needle see related information
Date Initiated by Firm December 18, 2018
Create Date February 07, 2019
Recall Status1 Terminated 3 on August 23, 2020
Recall Number Z-0814-2019
Recall Event ID 81968
510(K)Number K890925  
Product Classification Needle, biopsy, cardiovascular - Product Code DWO
Product "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Code Information Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU
Recalling Firm/
Manufacturer		 Angiotech (Manan Medical Products, Inc.)
241 W Palatine Rd
Wheeling IL 60090-5824
For Additional Information Contact Rebecca Ellis
469-731-1410
Manufacturer Reason
for Recall		 Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
FDA Determined
Cause 2		 Equipment maintenance
Action Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.
Quantity in Commerce 9,900 units
Distribution Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
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 = DWO and Original Applicant = MANAN MEDICAL PRODUCTS, INC.
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