Date Initiated by Firm | June 02, 2016 |
Date Posted | July 12, 2016 |
Recall Status1 |
Terminated 3 on August 21, 2017 |
Recall Number | Z-2201-2016 |
Recall Event ID |
74489 |
510(K)Number | K810675 |
Product Classification |
Wire, guide, catheter - Product Code DQX
|
Product | Femoral Arterial Line
Catheterization Kit with Sharps Safety Features
510K 810675, product code DQX, Device Listing D025180
Material ASK-04018-VUH
Product Usage:
The Arrow arterial catheterization device permits access to the peripheral arterial circulation. |
Code Information |
Lot/Batch Numbers: 23F14M0829, 23F14M0986 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact | Customer Service 855-419-8507 |
Manufacturer Reason for Recall | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com.
For questions contact your local sales representative or Customer Service at
1-866-246-6990. |
Quantity in Commerce | 50 units in total |
Distribution | US distribution in the states of TN 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
|