ARROW Endurance Extended Dwell Peripheral Catheter System
FDA Recall Z-1826-2023 · Posted 2023-06-21
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Recalling FirmARROW INTERNATIONAL Inc.
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2023-05-19
Product Quantity262,016 units
Reason for Recall
Potential for catheter separation or leakage
Firm Action
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 [email protected]. 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: [email protected]
If you have any questions, please contact your local Teleflex sales representative or Teleflex Customer Service.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide distribution. International distribution to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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