Recall Z-2015-2018 ยท OBJ Catheter, Ultrasound, Intravascular
Arrow International Inc
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
| Date | Apr 11, 2018 |
| Status | Terminated |
| Reason | Product sterility may be compromised due to unsealed packaging. |
| Root cause | Under Investigation by firm |
| Action | On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. 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 |
| Quantity | 416,055 total products |
| Distribution | US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWED |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132133 | CG+ ARROW JACC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 26, 2013 |