Date Initiated by Firm |
August 08, 2016 |
Date Posted |
September 07, 2016 |
Recall Status1 |
Terminated 3 on August 22, 2017 |
Recall Number |
Z-2740-2016 |
Recall Event ID |
74986 |
510(K)Number |
K810675
|
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product |
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels. |
Code Information |
Device Listing # D025180 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact |
Alice Harper 610-378-0131 Ext. 3548
|
Manufacturer Reason for Recall |
Shipping carton labeling error.
|
FDA Determined Cause 2 |
Process control |
Action |
Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. 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 all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990. |
Quantity in Commerce |
690 kits |
Distribution |
Nationwide Distribution to OH, IN, TN, NC, and KY. |
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 = DQX and Original Applicant = ARROW INTL., INC.
|