Recall Z-2773-2016 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
| Date | Feb 17, 2016 |
| Status | Terminated |
| Reason | Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com, even if you do not |
| Quantity | 6,121 units in total |
| Distribution | US Distribution to states of: NC, OH, FL, and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061289 | ARROW PRESSURE INJECTABLE PICC Arrow International, Inc., Aug 24, 2006 |