Recall Z-1984-2019 ยท OCT Anti Fog Solution And Accessories, Endoscopy
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
| Date | Jul 18, 2019 (initiated May 30, 2019) |
| Status | Open, Classified |
| Reason | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 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 distribution to Canada and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER Deroyal Industries, Inc., Aug 11, 1998 |