AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2801-2026