* (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 F
FDA device recall Z-0165-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
- Action taken
- Recalling firm notified all distributors by phone from 9/30 - 10/1/09. All customers were notified by letter titled "URGENT: DEVICE RECALL" dated 09/30/2009 on 10/2/2009. Customers were instructed to check their inventory for the affected product, complete the reply form and return affected product. For questions, please contact Damaris Velez or Jeff Dickinson of ConMed Electrosurgery at 800-552-0138, ext 5225 or email succoagrecall AT conmed.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2700 units
- Distribution
- US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA
- Date initiated
- 2009-09-30
- Date posted
- 2009-11-10
- Date terminated
- 2010-03-16
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION (K052104) | Conmed Corporation | 2005-10-21 |