Recalls / —

—#160107

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.

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K810675

Affected lot / code info

Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547

Why it was recalled

Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

...

Timeline

Recall initiated

2017-07-10

Terminated

2018-09-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #160107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.