Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318, .038/300 cm, regular/angled/stand
FDA device recall Z-1298-2009 · posted 2009-05-26 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.
- Action taken
- 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
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 75 units
- Distribution
- 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, T
- Date initiated
- 2009-02-26
- Date posted
- 2009-05-26
- Date terminated
- 2010-01-07
- Location
- Athens, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905) | Maxxim Medical | 2001-08-28 |