Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC

FDA device recall Z-1984-2019 · posted 2019-07-18 · Open, Classified

Recall details

Recalling firm

Medline Industries, Inc.

Reason for recall

The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

Action taken

Medline Industries, Inc. notified customers on about 05/30/2019 via "URGENT NOTICE: MEDICAL DEVICE RECALL ANTI-FOG SOLUTION" letter. Customers were instructed to examine inventory for the affected kit numbers and lot numbers, quarantine any affected kits, and affix the provided stickers on the affected kits advising to not use the Anti-Fog Solution components, discard any from the pack at point of use, and pull another approved product from the sterile supply. Single, sterile replacement product for the Anti-Fog Solution is available upon request. Customers were also instructed to complete and return the provided verification form listing the quantity of affected product on hand, even if it is none, and to also promptly notify any customers if the product was further distributed. Questions can be directed to Benjamin Gora at 1-866-359-1704.

Root cause

Device Design

Status

Open, Classified

Product code

OCT

Quantity affected

14,550 units

Distribution

Nationwide distribution to AL, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, WY. Worldwide distributio

Date initiated

2019-05-30

Date posted

2019-07-18

Location

Waukegan, IL

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