Z-0486-2018Class II

Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral...

Name: Z-0486-2018 Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral...
Creator: Arrow International Inc
Published: 2017-07-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-07-10 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of 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 on 2017-07-10. FDA classified it as Class II and gives the reason as "Needle supplier indicated the presence of loose polypropylene foreign matter above release specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0486-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-10
Posted: 2018-02-13
Terminated: 2018-09-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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.
Distribution: ...
Product codes and lots: Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0486-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code FMI

K810675Class IIArrow Radial Artery Catheterization SetArrow Intl., Inc. / cleared 1981-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)