Recall Z-2462-2015 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
| Date | Aug 25, 2015 (initiated Jul 30, 2015) |
| Status | Terminated |
| Reason | the catheter peel-away component hub tabs may prematurely detach. One injury reported. |
| Root cause | Unknown/Undetermined by 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 recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number |
| Quantity | 52109 |
| Distribution | US Nationwide Distribution and internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042126 | PICC Arrow Intl., Inc., Aug 27, 2004 |
| K061289 | ARROW PRESSURE INJECTABLE PICC Arrow International, Inc., Aug 24, 2006 |
| K073451 | PRESSURE INJECTABLE PICC Arrow International, Inc., Jan 15, 2008 |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET Vasonova, Inc., Feb 18, 2011 |
| K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER Teleflex, Inc., May 16, 2012 |
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 7, 2012 |