Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/ang
FDA device recall Z-0882-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 300
- 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.
- Date initiated
- 2007-11-19
- Date posted
- 2008-01-31
- Date terminated
- 2008-06-05
- Location
- Athens, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905) | Maxxim Medical | 2001-08-28 |