AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in ang
FDA device recall Z-0135-2013 · posted 2012-10-25 · Terminated
Recall details
- Recalling firm
- Nipro Medical Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 1500
- 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.
- Date initiated
- 2012-07-27
- Date posted
- 2012-10-25
- Date terminated
- 2013-05-25
- Location
- Miami, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNIPER, MODEL OR-3872XX SERIES (K001251) | Nipro Medical Corp. | 2000-07-07 |