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Terminated

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 Recall Z-2203-2019 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeMNL
Date Initiated2019-04-25
Date Terminated2020-12-16
Product Quantity22204

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.

Firm 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.

Root Cause

Other

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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