Video Duodenoscope
Recall
- Recall Number
- Z-1835-2016
- Event Number
- 73377
- Firm
- Pentax Medical Company
- FEI Number
- 1000080301
- Product Code
- FDT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 22, 2016
- Terminated
- December 6, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782
Description
Video Duodenoscope
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
Pentax Inc. issued an "Urgent Field Correction" Letter dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provides information regarding the updated Reprocessing instruction for use along with some main changes in the Operation IFU. Instructions are also provided regarding prior versions of the Reprocessing and Operation Instructions for Use. A web posting went live on 2/19/2016. For further questions, please call: Tel:800-431-5880 ext. 2064 (8:30AM- 5:00 PM, Monday-Friday, EST)
Nationwide
423 units