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 AMS1
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) 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.
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 AMS13574AModel UDI B098AMS13574A0Model Lot Numbers: 235911Model 236897. 2) Pack Number AMS14710BModel UDI B098AMS14710B0Model Lot Numbers: 224717Model 230666Model 213914Model 236351. 3) Pack Number AMS14991AModel UDI B098AMS14991A0Model Lot Numbers: 215450Model 230108. 4) Pack Number AMS14991BModel UDI B098AMS14991B0Model Lot Numbers: 233346. 5) Pack Number AMS16278Model UDI B098AMS162780Model Lot Numbers: 219872Model 222999Model 226497Model 229309Model 236465Model 237544Model 238613. 6) Pack Number AMS16499Model UDI B098AMS164990Model Lot Numbers: 215711Model 218234Would 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.