Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
This recall has been terminated (originally issued November 15, 2019).
- Company
- Arrow International Inc
- Recall Initiated
- November 15, 2019
- Terminated
- June 19, 2020
- Recall Number
- Z-0715-2020
- Quantity
- 71 units
- Firm Location
- Reading, PA
- Official Source
- View on FDA website ↗
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
Distribution
U.S. Nationwide, Canada
Lot / Code Info
Lot Number: 16F19H0089
Root Cause
Process control
Action Taken
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. .