ARROW Endurance Extended Dwell Peripheral Catheter System
FDA device recall Z-1826-2023 · posted 2023-06-21 · Open, Classified
Recall details
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Reason for recall
- Potential for catheter separation or leakage
- Action taken
- Arrow International/Teleflex sent customers an "URGENT MEDICAL DEVICE RECALL" letter, via FedEx, on 05/19/2023. Customers were instructed to check for affected products in inventory, immediately discontinue use and quarantine the products and complete and return the Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Should you require further information or support concerning this issue, please contact Customer Service via email, phone, or FAX using the details provided below. Customer Service hours of operation are 8am 7pm EST. Contact: Customer Service Telephone: 1-866-396-2111 FAX: 1-855-419-8507 Email: Recalls@teleflex.com If you have any questions, please contact your local Teleflex sales representative or Teleflex Customer Service.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FOZ
- Quantity affected
- 262,016 units
- Distribution
- Nationwide distribution. International distribution to Canada.
- Date initiated
- 2023-05-19
- Date posted
- 2023-06-21
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Arrow Endurance Extended Dwell Peripheral Catheter System (K163513) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017-02-24 |