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 AMS6452
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) 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.
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 AMS12195CModel UDI B098AMS12195C0Model Lot Numbers: 217757Model 222686Model 224418Model 225587Model 227439Model 228598Model 230569Model 234138Model 235331Model 236869Model 238356. 2) Pack Number AMS12195DModel UDI B098AMS12195D0Model Lot Numbers: 240974. 3) Pack Number AMS12307Model UDI B098AMS12307Model Lot Numbers: 220948Model 234027Model 234756Model 235909Model 238000Model 239036Model 241680. 4) Pack Number AMS16313Model UDI B098AMS163130Model Lot Numbers: 241787. 5) Pack Number AMS17958Would 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.