FDA Medical Device Recalls (openFDA)
Arrow International Inc: Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
- Recall number
- Z-0486-2018
- Recalling firm
- Arrow International Inc
- Product
- Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
- Status
- Terminated
- Initiated
- 2017-07-10
- Posted
- not on file
- Terminated
- 2018-09-14
- Reason
- Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
- Root cause
- Material/Component Contamination
- Action
- On July 10, 2017, Arrow International distributed Urgent Medical Device Recall notice and acknowledgment forms to customers. Customers are advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products listed in the notice, 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 return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 18662466990.
- Quantity
- not on file
- Distribution
- ...
- Lot, serial or model codes
- Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547
- 510(k) numbers
- ["K810675"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28