PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
FDA Recall Z-2462-2015 · Posted 2015-08-25
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2015-07-30
Date Terminated2018-06-28
Product Quantity52109
Reason for Recall
the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notificatin letters dated July 30, 2015 to their affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. immediately discontinue use and quarantine any products with the catalog
and lot number provided in the notice. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507
Attn: Customer Service or email it to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to
Arrow International. 3. Customers were also asked to complete the enclosed Recall Acknowledgment Form if there is no affected product, this will allow for documented receipt of this letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide Distribution and internationally to Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K121941ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.) · 2012-09-07K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc. · 2012-05-16K103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETVasonova, Inc. · 2011-02-18K073451PRESSURE INJECTABLE PICCArrow International, Inc. · 2008-01-15K061289ARROW PRESSURE INJECTABLE PICCArrow International, Inc. · 2006-08-24K042126PICCArrow Intl., Inc. · 2004-08-27
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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