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Class 2 Device Recall Arrow CVC |
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Date Initiated by Firm |
November 14, 2018 |
Create Date |
January 11, 2019 |
Recall Status1 |
Terminated 3 on June 04, 2020 |
Recall Number |
Z-0723-2019 |
Recall Event ID |
81665 |
510(K)Number |
K862056
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Product Classification |
Catheter, percutaneous - Product Code DQY
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Product |
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402
The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products |
Code Information |
Lots 14F18F0336 & 14F18E0121 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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Manufacturer Reason for Recall |
The lidstock states the incorrect priming volume and flow rates.
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FDA Determined Cause 2 |
Error in labeling |
Action |
The firm, Teleflex, sent an "Urgent Medical Device Notification" letter dated 11/13/2018 to its customers on 11/14/2018. The letter described the product, problem and action to be taken. The customers were instructed to do the following:
1. Place a copy of this notification with each unit of affected product currently in your inventory.
2. Using the provided customer letter template and acknowledgement form, communicate this notification to any of your customer who have received product included within the scope of this notification.
3. Have each of your customers who received the affected product return a completed acknowledgement form to you.
4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of this notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document completion of this field action.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111. |
Quantity in Commerce |
15 in the US |
Distribution |
Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, 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 = DQY and Original Applicant = ARROW INTL., INC.
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