FDA recall Z-1899-2018

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)

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.

Key facts

Status

Terminated

Initiation date

2018-03-21

Report date

2018-05-30

Termination date

2019-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Branford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1899-2018