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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Marrow Aspiration Needle

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 Class 2 Device Recall Bone Marrow Aspiration Needlesee related information
Date Initiated by FirmJune 18, 2015
Date PostedJuly 21, 2015
Recall Status1 Terminated 3 on June 23, 2016
Recall NumberZ-2188-2015
Recall Event ID 71533
Product Classification Instrument, biopsy - Product Code KNW
ProductBone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Code Information Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707
Recalling Firm/
Manufacturer
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactRebecca Ellis
972-403-0749
Manufacturer Reason
for Recall
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
Packaging process control
ActionThe recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
Quantity in Commerce6390 units
DistributionUS
Total Product Life CycleTPLC 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.
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