Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .035/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
This recall has been terminated (originally issued May 26, 2009).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- February 26, 2009
- Posted
- May 26, 2009
- Terminated
- January 7, 2010
- Recall Number
- Z-1289-2009
- Quantity
- 1,566 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
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.
Lot / Code Info
All lot codes
Root Cause
Other
Action Taken
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.