Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEA

FDA device recall Z-3210-2018 · posted 2018-10-11 · Terminated

Recall details

Recalling firm

Medline Industries Inc

Reason for recall

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.

Action taken

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 Cleaning Brush were instructed to immediately check inventory for affected devices, destroy any affected devices, notify customers if the product has been further distributed, and complete and return the provided destruction form listing the quantity of affected products destroyed or that there was no product on hand to destroy.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MNL

Quantity affected

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, W

Date initiated

2018-06-15

Date posted

2018-10-11

Date terminated

2020-05-18

Location

Northfield, IL