Home / Recalls / Madison Polymeric Engineering / Z-1182-2018

Z-1182-2018 Class II Terminated

Recalled by Madison Polymeric Engineering — Branford, CT

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
November 3, 2017
Termination Date
July 17, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
285 cases

Product Description

First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

Reason for Recall

Affected lots may have exceeded its microbial limits.

Distribution Pattern

US Distribution. .

Code Information

EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A

Other recalls by Madison Polymeric Engineering

  • Z-1925-2019 Class II — First Step Draco Pad, Product Number EP-4D (May 8, 2019)
  • Z-1924-2019 Class II — Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product (May 8, 2019)
  • Z-0969-2019 Class II — Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Mu (December 14, 2018)
  • Z-1895-2018 Class II — First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1899-2018 Class II — Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexibl (March 21, 2018)
  • Z-1896-2018 Class II — First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-1897-2018 Class II — First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endosco (March 21, 2018)
  • Z-1900-2018 Class II — Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Dete (March 21, 2018)
  • Z-1898-2018 Class II — First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean (March 21, 2018)
  • Z-2211-2017 Class II — Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY (April 17, 2017)