Branford, CT, United States
Madison Polymeric Engineering recalls
4 recalls recorded since 2018, most recently on 8 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 May 2019
- Terminated
- 6 July 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1925-2019, Z-1924-2019
- First Step Draco Pad, Product Number EP-4D
- Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
Terminated Class II Medical devices
- Recall started
- 14 December 2018
- Terminated
- 31 December 2019
- Reason
- The product is contaminated with Pseudomonas.
- Distribution
- Worldwide Distribution - US states: CA, FL, IL, IN, NJ, NY, PA, and TN. The products were distributed to the following foreign countries: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0969-2019
- Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and
Terminated Class II Medical devices
- Recall started
- 21 March 2018
- Terminated
- 9 April 2019
- Reason
- The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- Distribution
- The products were distributed to the following US states: AK, AL, AR, CA, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI. The products were also distributed in Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1895-2018, Z-1899-2018, Z-1896-2018, Z-1898-2018, Z-1897-2018, Z-1900-2018
- First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3
- Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
- First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
- First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
- First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
- Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
Terminated Class II Medical devices
- Recall started
- 3 November 2017
- Terminated
- 17 July 2018
- Reason
- Affected lots may have exceeded its microbial limits.
- Distribution
- US Distribution. .
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1182-2018
- 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. Prod
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.