Arrow International Inc Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

Recommended Action

Per FDA guidance

On May 17, 2019, Arrow International issued Urgent Medical Device and Acknowledgement notices to customers via courier service. Customers should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Distributors should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate the notification to any of your customers who have received product included within the scope of the notification. 3. Have each of your customers who received the affected product return a completed acknowledgement form to you. 4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of the notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form and fax it to 1-855- 419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document completion of this field action If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.