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.
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510(K) Database | 510(K)s with Product Code = DQY
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