Recall Z-1306-2009 ยท DQX Wire, Guide, Catheter
Argon Medical Devices, Inc
Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Texas 77008, (713) 863-1600 Fax 713 863-1601, www.totalvein.com.
| Date | May 26, 2009 (initiated Feb 26, 2009) |
| Status | Terminated |
| Reason | Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding. |
| Root cause | Other |
| Action | Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319. |
| Quantity | 750 units |
| Distribution | Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES Maxxim Medical, Aug 28, 2001 |