Home / Recalls / Madison Polymeric Engineering / Z-1925-2019

Z-1925-2019 Class II Terminated

Recalled by Madison Polymeric Engineering — Branford, CT

FDA device recall Z-1925-2019 was initiated by Madison Polymeric Engineering on May 8, 2019 and is designated Class II. Reason for recall: This product has been contaminated with Stenotrophomonas lactiubi. The recall status is terminated (terminated July 6, 2020). Affected quantity: 10570.

Recall Details

Product Type: Devices
Report Date: July 10, 2019
Initiation Date: May 8, 2019
Termination Date: July 6, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10570

Product Description

First Step Draco Pad, Product Number EP-4D

Reason for Recall

This product has been contaminated with Stenotrophomonas lactiubi.

Distribution Pattern

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

Code Information

Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X

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