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 Recall Z-0486-2018 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFMI
Date Initiated2017-07-10
Date Terminated2018-09-14
Reason for Recall
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
...
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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