Recall Z-0819-2012
Pentax Medical Company · initiated September 30, 2011
Product
EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
Codes / lots: EE-1580K A110273
Reason for recall
The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
FDA-determined cause: Employee error
Action taken
Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
Details
- Recall number
- Z-0819-2012
- Initiated
- September 30, 2011
- Posted by FDA
- January 20, 2012
- Terminated
- November 27, 2012
- Product code
- EOX – Esophagoscope (Flexible Or Rigid)
- Quantity
- one unit
- Distribution
- Nationwide Distribution.
- Recalling firm
- Pentax Medical Company, Montvale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0818-2012 | EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical…The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the… | 09/30/2011Terminated |
| Z-0820-2012 | EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical…The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the… | 09/30/2011Terminated |