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.
Windstone Medical Packaging, Inc.
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) Pack Number AMS12206Model UDI B098AMS122060Model Lot Numbers: 201002Model 205119Model 206649Model 211870Model 215233Model 217552Model 218967Model 219166Model 222076Model 224914Model 227000Model 228485Model 230336Model 231348Model 232214Model 238290Model 239795Model 241802. 2) Pack Number AMS15517Model UDI B098AMS155170Model Lot Numbers: 215924Model 218494Model 235207Model 241105. 3) Pack Number AMS15863AWould you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.