Recall StatusTerminated
Date Initiated2013-10-09
Date Terminated2015-08-12
Product Quantity294430
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.
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.