Skip to content
Recall Observatory FDA recall evidence

Device product

First Step Draco Pad, Product Number EP-4D

Z-1925-2019

May 08, 2019

Class II

Product summary

Firm
Madison Polymeric Engineering
Event
Event 82971
Status
Terminated
Classification
Class II
Quantity
10570
Official record key
device-enforcement:Z-1925-2019

Official wording

Reason: This product has been contaminated with Stenotrophomonas lactiubi.

Code information: Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X

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.