Recall Z-3210-2018 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Medline Industries Inc
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SB
| Date | Oct 11, 2018 (initiated Jun 15, 2018) |
| Status | Terminated |
| Reason | There is 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 | Under Investigation by firm |
| Action | Medline notified customers on about 06/15/2018 via URGENT RECALL MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED letter. Accounts that purchased a custom kit or standard Pack were instructed to immediately check inventory for affected devices, quarantine any affected devices, affix the provided stickers on affected kits and continue use but were instructed to not use the Endoscopic Cleaning Brush in the kit and to instead pull another approved product from inventory. They were also instructed to complete and return the Verification Form. Accounts that just purchased the Endoscopic Clea |
| Quantity | 183,606 devices total |
| Distribution | Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.