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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow TwoLumen Central Venous Catheterization

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  Class 2 Device Recall Arrow TwoLumen Central Venous Catheterization see related information
Date Initiated by Firm January 10, 2019
Create Date April 10, 2019
Recall Status1 Terminated 3 on June 04, 2020
Recall Number Z-1118-2019
Recall Event ID 82070
510(K)Number K862056  
Product Classification Catheter, percutaneous - Product Code DQY
Product Arrow¿ Two-Lumen Central Venous Catheterization
Kit with Blue FlexTip¿ Catheter
Product Code: AH-11802 (OUS)
GTN: 00801902026132
Code Information Lot Numbers:  71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact see above
610-378-0131
Manufacturer Reason
for Recall		 The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
FDA Determined
Cause 2		 Error in labeling
Action Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form
Quantity in Commerce None (US)
Distribution FL, NC
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 = DQY and Original Applicant = ARROW INTL., INC.
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