Recalls / —
—#80654
Product
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
- FDA product code
- DQX — Wire, Guide, Catheter
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K011905
- Affected lot / code info
- All lot codes
Why it was recalled
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2009-02-26
- Posted by FDA
- 2009-05-26
- Terminated
- 2010-01-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #80654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.