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Recall Observatory FDA recall evidence

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

March 21, 2018

Class II

Product summary

Firm
Madison Polymeric Engineering
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

    reason.microbial_contamination · v1.0.0

    microbial contamination