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Terminated

First Step Draco Pad, Product Number EP-4D

FDA Recall Z-1925-2019 · Posted None

Recalling FirmMadison Polymeric Engineering
Recall StatusTerminated
Product CodeMNL
Date Initiated2019-05-08
Date Terminated2020-07-06
Product Quantity10570

Reason for Recall

This product has been contaminated with Stenotrophomonas lactiubi.

Firm Action

Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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