Recall Z-1389-2016— Cygnus Medical
Class III · Terminated
Class III FDA medical device recall by Cygnus Medical, initiated 2016-03-17, terminated 2016-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).. Reason: Foreign material in container.
- Recalling firm
- Cygnus Medical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-03-17
- Terminated
- 2016-05-23
- Firm location
- Branford, CT, United States
Product description
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
Reason for recall
Foreign material in container
Data sourced from openFDA. This site is unofficial and independent of the FDA.