Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. VisioMed International Group Inc., 14555 South Robert Trail - #208, Rosemount, MN 55068, www.visiomedical.com.
FDA Recall Z-1307-2009 · Posted 2009-05-26
Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2009-02-26
Date Terminated2010-01-07
Product Quantity50 units
Reason for Recall
Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
Firm 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.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.