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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Needle

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  Class 2 Device Recall Bone Needle see related information
Date Initiated by Firm January 18, 2017
Date Posted February 13, 2017
Recall Status1 Terminated 3 on May 17, 2017
Recall Number Z-1194-2017
Recall Event ID 76292
510(K)Number K980196  
Product Classification Instrument, biopsy - Product Code KNW
Product BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX

Intended for the purpose of harvesting bone and/or bone marrow specimens
Code Information lots: 11156986, 11158618, 11158620
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Rebecca Ellis
903-403-0749
Manufacturer Reason
for Recall		 The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
FDA Determined
Cause 2		 Equipment maintenance
Action Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.
Quantity in Commerce 497 boxes
Distribution Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
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 = MEDICAL DEVICE TECHNOLOGIES, INC.
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