Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction

FDA device recall Z-0468-2014 · posted 2013-12-09 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

Action taken

Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-800-343-2935. For questions regarding this recall call 610-378-0131.

Root cause

Process control

Status

Terminated

Product code

DYB

Quantity affected

294430

Distribution

Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.

Date initiated

2013-10-09

Date posted

2013-12-09

Date terminated

2015-08-12

Location

Reading, PA

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