The Recall Desk
ModerateFDA (Devices)·Z-1389-2016·Announced 2016-04-20

Cygnus Medical First Step Bedside ADDWATER Kit Recalled for Foreign Material

Cygnus Medical is recalling First Step Bedside ADDWATER Kits due to foreign material found in the containers. The recall affects 39 cases distributed to 13 US states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is foreign material in the container, which is a quality control issue rather than a high-risk biological or chemical contamination.

Plain-English summary

Cygnus Medical is recalling its First Step Bedside ADDWATER Kit, a non-sterile product used for the initial cleaning of flexible endoscopes. The recall is being conducted because foreign material was found in the containers. The affected product, identified by SKU# EP-6W, consists of a 500 ml kit containing concentrated Simple2 Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch.

The recall involves 39 cases of 120 units each. The affected lot numbers are EX20170714A and EX201720A. These products were distributed in the United States to the states of California, Colorado, Florida, Illinois, Minnesota, Montana, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont, Washington, and Wisconsin.

Healthcare facilities and consumers who have this product should stop using it and contact Cygnus Medical for instructions on how to return the product or obtain a refund.

The recalled product

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).
Manufacturer
Cygnus Medical
Category
Medical Device — Endoscope Cleaning
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: EX20170714A and EX201720A

Distribution

Distributed in 14 states:

Related recalls

Same hazard · foreign material

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