—#79590

Product

Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/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 #79590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.