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Recall Observatory FDA recall evidence

Device product

Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.

Z-2203-2019

April 25, 2019

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 83323
Status
Terminated
Classification
Class II
Quantity
22204
Official record key
device-enforcement:Z-2203-2019

Official wording

Reason: Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

Code information: KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20

Distribution pattern: US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.