Recall Z-0716-2020 ยท DYG Catheter, Flow Directed
Arrow International Inc
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
| Date | Nov 15, 2019 |
| Status | Terminated |
| Reason | 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 | 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 Au |
| Quantity | 1 unit |
| Distribution | U.S. Nationwide, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892530 | CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH Arrow Intl., Inc., Sep 26, 1989 |