Recall Z-1835-2016 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Pentax Medical Company
Video Duodenoscope
| Date | Feb 22, 2016 |
| Status | Terminated |
| Reason | Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility. |
| Root cause | Other |
| Action | 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 |
| Quantity | 423 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP Evenflo Company, Inc., Oct 9, 2009 |