Device product
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Z-1897-2018
Product summary
- Event
- Event 79826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases/210 kits
- Official record key
device-enforcement:Z-1897-2018
Official wording
Reason: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Code information: Lot Numbers: EX20190103P
Distribution pattern: 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.
Derived failure modes
-
Microbial contamination
microbial contamination