Z-2203-2019 Class II Terminated
FDA device recall Z-2203-2019 was initiated by Medline Industries Inc on April 25, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 16, 2020). Affected quantity: 22204.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- April 25, 2019
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22204
Product Description
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Reason for Recall
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.
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
Code Information
KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20