Recall Z-2576-2018 ยท DYB Introducer, Catheter
Arrow International Inc
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
| Date | May 23, 2018 |
| Status | Terminated |
| Reason | Product contains dry natural rubber latex. Label states Latex Free. |
| Root cause | Process control |
| Action | On May 23, 2018, Arrow International issued Urgent Medical Device Recall notices and response forms to their customer. Customers are advised to take the following actions: 1. Immediately discontinue distribution and quarantine affected product. 2. Using the provided customer letter and Recall Acknowledgement Form templates, customers who have further distributed product should contact those individuals. 3. To return affected products from your inventory, complete and return the Recall Acknowledgement Form via to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 4. If |
| Quantity | 60 units |
| Distribution | Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |