Class 2 Device Recall

• Date Initiated by Firm: November 15, 2019
• Create Date: December 19, 2019
• Recall Status: Terminated on June 19, 2020
• Recall Number: Z-0715-2020
• Recall Event ID: 84399
• 510(K)Number: K892530
• Product Classification: Catheter, Flow Directed - Product Code DYG
• Product: Arrow Berman Angiographic Catheter 50cc; Item Number: AI-07130
• Code Information: Lot Number: 16F19H0089
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: SAME; 610-378-0131
• Manufacturer Reason for Recall: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
• FDA Determined Cause: Process control
• Action: Arrow International issued letters on 11/15/19 stating reason for recall, health risk, and action to take: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or 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 Teleflex Medical. 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 ema il recalls@teleflex.com. your local sales representative or Customer Service at 1-866-396-2111. .
• Quantity in Commerce: 71 units
• Distribution: U.S. Nationwide, Canada
• 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 = DYG and Original Applicant = ARROW INTL., INC.