Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- November 19, 2007
- Posted
- January 31, 2008
- Terminated
- June 5, 2008
- Recall Number
- Z-0883-2008
- Quantity
- 444
- Firm Location
- Athens, TX
Reason for Recall
Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
Distribution
Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.
Lot / Code Info
Lot Numbers: 99508645, 99497398, and 99535020
Root Cause
Process design
Action Taken
Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.
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