FDA recall Z-1925-2019

Madison Polymeric Engineering · Class II · device

Product

First Step Draco Pad, Product Number EP-4D

Reason for recall

This product has been contaminated with Stenotrophomonas lactiubi.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-05-08
Report date
2019-07-10
Termination date
2020-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Branford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1925-2019