Recall Z-2203-2019 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Medline Industries Inc
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
| Date | Apr 25, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | On April 25, 2019, the firm sent Additional Items - Lots Affected URGENT RECALL MEDLINE INDUSTRIES IMMEDIATE ACTION REQUIRED letters to 61 consignees advising them of the problem, requesting that they apply stickers to any subject item/lot, and return the Verification Form. On May 15, 2019, the firm sent out a second recall letter to 36 consignees. |
| Quantity | 22204 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.