Device product
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)
Z-1899-2018
Product summary
- Event
- Event 79826
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 cases/1150 kits
- Official record key
device-enforcement:Z-1899-2018
Official wording
Reason: The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Code information: Lot Numbers: EX20190103P, EX20190105P, EX20190111P, EX20190112P, EX20181220P, EX20181227P, EX20181228P, EX20181229P
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