Z-1389-2016Class III

Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU#...

Name: Z-1389-2016 Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU#...
Creator: Cygnus Medical
Published: 2016-03-17
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2016-03-17 / Terminated / root cause: packaging

FDA source

Cygnus Medical began a recall of 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... on 2016-03-17. FDA classified it as Class III and gives the reason as "Foreign material in container". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1389-2016
Classification: Class III
Status: Terminated
Initiated: 2016-03-17
Posted: 2016-04-14
Terminated: 2016-05-23
Recalling firm: Madison Polymeric Engineering
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).
Product code: MNL Accessories, Cleaning Brushes, For Endoscope
Reason for recall: Foreign material in container
Root cause tag: packaging
FDA root cause: Packaging
Action: Cygnus Medical LLC sent an Recall Notice letter certified mail to direct customers and receivers on March 17, 2016. The letter identified the product the problem and the action needed to be taken by the customer. The letter was preceded with an email or fax to expedite notification. Customers to respond via fax or email regarding the quantities in their possession, including a response where the quantity is zero. Returns to made to firm. Contact Quality Manager Cygnus Medical LLC, phone: (203) 488-4554 x 105 fax: (203) 764-1858.Email: [email protected]. For further questions, please call (203) 488-4554.
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: EX20170714A and EX201720A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1389-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1389-2016	Class III	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code MNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)