Device product
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Z-1898-2018
Product summary
- Event
- Event 79826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 359 cases/10770 kits
- Official record key
device-enforcement:Z-1898-2018
Official wording
Reason: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Code information: Lot Numbers: EX20181220P, EX20181221P, EX20181222P, EX20181226P, EX20181228P, EX20190103P, EX20190105P
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