Recall Z-0136-2013 ยท DQX Wire, Guide, Catheter
Nipro Medical Corporation
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
| Date | Oct 25, 2012 (initiated Jul 27, 2012) |
| Status | Terminated |
| Reason | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. |
| Root cause | Equipment maintenance |
| Action | Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice. |
| Quantity | 100 |
| Distribution | Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001251 | SNIPER, MODEL OR-3872XX SERIES Nipro Medical Corp., Jul 7, 2000 |