United StatesAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits (examples include ENT, Rhinoplasty, Spine, Septoplasty, Laryngoscopy, Nasal and Sinus, Major, Neuro, Laminectomy, ACDF/Fusion and other packs) identified by the many listed pack/part numbers, UDIs and lot numbers are affected. The recall was initiated because Medicom recalled specific lots of Ritmed Neurological Sponges (non-sterile models 55992C–55998C) for potential unexpected variability of endotoxin levels on the products.
What's being recalled
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A…
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
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.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771.
Recalling firm: Windstone Medical Packaging, Inc., Billings, MT, United States.
How to identify it
1) Pack Number AMS10411B, UDI B098AMS10411B0, Lot Numbers: 219316, 221418, 225796, 227963, 229410, 231465, 232835, 234875, 236009. 2) Pack Number AMS10411C, UDI B098AMS10411C0, Lot Numbers: 237159, 239012. 3) Pack Number AMS11963A, UDI B098AMS11963A0, Lot Numbers: 219232, 221841, 231180, 233233, 235232, 237047, 239415. 4) Pack Number AMS12636C, UDI B098AMS12636C0, Lot Numbers: 216052, 216353, 219607, 222572, 227336, 228169, 232135, 232908, 236235, 242190. 5) Pack Number AMS12731, UDI B098AMS127310, Lot Numbers: 211494, 219640, 224583, 225855, 226678, 228322, 231368, 241824. 6) Pack Number AMS13150, UDI B098AMS131500, Lot Numbers: 172113, 190090, 196504, 197866, 199463, 199844, 201971. 7) Pack Number AMS13150A, UDI B098AMS13150A0, Lot Numbers: 202549, 204081, 209263, 210230, 211511, 213173, 215672. 8) Pack Number AMS13150B, UDI B098AMS13150B0, Lot Numbers: 216273, 216809, 218664, 219473, 222602, 224670, 225793, 227885, 229995, 232849, 234167, 235630, 236695, 237697, 239909, 241667. 9) Pack Number AMS14496A, UDI B098AMS14496A0, Lot Numbers: 207772, 219739. 10) Pack Number AMS14496B, UDI B098AMS14496B0, Lot Numbers: 223681, 224699, 226316, 227598. 11) Pack Number AMS14496C, UDI B098AMS14496C0, Lot Numbers: 231376, 237310. 12) Pack Number AMS14736, UDI B098AMS147360, Lot Numbers: 192735, 204268, 222714, 226621. 13) Pack Number AMS16417, UDI B098AMS164170, Lot Numbers: 217216, 219433, 219463, 229357, 235439, 237701, 241666. 14) Pack Number AMS16586, UDI B098AMS16586, Lot Numbers: 229154, 230255. 15) Pack Number AMS16586A, UDI B098AMS16586A0, Lot Numbers: 233268, 233269, 233688, 233689, 235659, 236978, 237621, 238623, 239249, 241987. 16) Pack Number AMS7619A, UDI B098AMS7619A0, Lot Numbers: 176227, 179354, 184684, 186205, 187036, 188521, 189734, 191564, 195253, 197149, 202475, 202880, 205844, 206922, 210055, 211416, 212266, 215112, 217611, 218240, 219633, 221172, 223315, 225142, 226992, 229948, 231847, 232319, 234276, 235042, 239240, 241617. 17) Pack Number AMS7819A…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)