Recall Z-0884-2008 ยท DQX Wire, Guide, Catheter
Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387308, .035/180cm, 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
| Date | Jan 31, 2008 (initiated Nov 19, 2007) |
| Status | Terminated |
| Reason | Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 121 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES Maxxim Medical, Aug 28, 2001 |