—#178236

Product

Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130

FDA product code: DYG — Catheter, Flow Directed
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K892530
Affected lot / code info: Lot Number: 16F19H0089

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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. .

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: U.S. Nationwide, Canada

Timeline

Recall initiated: 2019-11-15
Terminated: 2020-06-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.