Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
FDA Recall Z-1228-2017 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2017-01-11
Date Terminated2018-09-06
Product Quantity215,703 units
Reason for Recall
There have been complaints for peel away sheaths flaring
Firm Action
Arrow International mailed an Urgent Medical Device Advisory Notification letter to affected customers on 01/13/2017 to inform them of the issue. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
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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