The FDA and Pentax announced a voluntary recall of all ED-3490TK video duodenoscopes to replace a series of parts and update the operations manual, Medscape reports.
Here's what you should know:
1. Pentax will update the forceps elevator mechanism, O-rings and the distal end covering on all recalled devices.
2. In addition, Pentax will update the operations manual to recommend annual maintenance for the scope.
3. Pentax believes the design changes will reduce contamination potential.
4. The FDA cleared the updated design and labeling changes for the ED-3490TK Feb. 7. Pentax sent a letter to all customers about the changes.
5. The duodenoscopes' complex design "may hinder effective reprocessing," Medscape reports. The scopes have been the subject of several recalls to fight infections associated with inadequate reprocessing.