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Class 2 Device Recall ARROW OnControl |
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Date Initiated by Firm |
November 08, 2016 |
Create Date |
November 30, 2016 |
Recall Status1 |
Terminated 3 on November 20, 2019 |
Recall Number |
Z-0679-2017 |
Recall Event ID |
75637 |
510(K)Number |
K142377
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Product Classification |
Instrument, biopsy - Product Code KNW
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Product |
ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients |
Code Information |
Material # 9471-VC-006, Lot numbers: 013107, 013260, 013889, 014126 & 014324; Material # 9472-VC-006, Lot numbers: 013108 & 013261; Material # 9403-VC-006, Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact |
Michael T. Taggart 919-433-4940
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Manufacturer Reason for Recall |
Sterility: Due to a potential incomplete seal on the outer sterile package.
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FDA Determined Cause 2 |
Device Design |
Action |
Teleflex sent an Urgent Medical Device Recall Notification letter dated November 8, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product, complete the enclosed Recall Acknowledgement Form and fax to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990.
For questions regarding this recall call 919-433-4940. |
Distribution |
Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = KNW and Original Applicant = VIDACARE LLC
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