First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
This recall has been terminated (originally issued March 21, 2018).
- Company
- Madison Polymeric Engineering
- Recall Initiated
- March 21, 2018
- Terminated
- April 9, 2019
- Recall Number
- Z-1897-2018
- Quantity
- 3 cases/210 kits
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
Lot Numbers: EX20190103P
Root Cause
Under Investigation by firm
Action Taken
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following: 1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1. 2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us. 3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.