Windstone Medical Packaging, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
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; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.
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, UDI B098AMS7819A0, Lot Numbers: 173334, 176639, 177152, 180388, 182683, 186406, 190810, 192202, 192848, 194365, 197188, 199488, 202783, 205388, 206750, 211253, 212412, 215250, 216089, 217246, 220359, 223776, 225483, 226654, 229721, 232212, 233317, 233852, 236921, 238278, 242389.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →