Date Initiated by Firm | July 10, 2017 |
Create Date | February 13, 2018 |
Recall Status1 |
Terminated 3 on September 14, 2018 |
Recall Number | Z-0486-2018 |
Recall Event ID |
78681 |
510(K)Number | K810675 |
Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
|
Product | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. |
Code Information |
Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact | Karen Boylan 610-378-0131 |
Manufacturer Reason for Recall | Needle supplier indicated the presence of loose polypropylene foreign matter above release specification. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | On July 10, 2017, Arrow International distributed Urgent Medical Device Recall
notice and acknowledgment forms to customers. Customers are
advised to take the following actions:
1. If you have affected stock, immediately discontinue use and quarantine any products listed in the notice, so that the affected products can be returned to Arrow.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419- 8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you
with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 18662466990. |
Distribution | ... |
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 = FMI
|