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Recall Observatory FDA recall evidence

Device product

Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z

Z-1924-2019

May 08, 2019

Class II

Product summary

Firm
Madison Polymeric Engineering
Event
Event 82971
Status
Terminated
Classification
Class II
Quantity
2723
Official record key
device-enforcement:Z-1924-2019

Official wording

Reason: This product has been contaminated with Stenotrophomonas lactiubi.

Code information: Lot Numbers EX20191121P EX20191126P EX20191127P EX20191212X EX20191213X EX20200125X

Distribution pattern: The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This product has been contaminated with Stenotrophomonas lactiubi.