Medline Industries, Inc. Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP N Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.