—#174726

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.

FDA product code: MNL — Accessories, Cleaning Brushes, For Endoscope
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

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

Timeline

Recall initiated: 2019-04-25
Terminated: 2020-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.