Cygnus Medical First StepBedside ADDWATER Kit recall: Foreign Material
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…
Why was Cygnus Medical First StepBedside ADDWATER Kit recalled?
Foreign material in container
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: EX20170714A and EX201720A
- 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…
- Recalling firm
- Cygnus Medical
- Quantity
- 39 cases of 120 units
- Distribution
- US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
- Recall date
- April 20, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)