A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Windstone Medical Packaging, Inc.
The hazard
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI/DI noneModel Lot Codes: 237663Model 237901Model 237957Model 238041Model 238084Model 238085Model 238146Model 238197Model 238589Model 239157Model 239216Model 239286Model 239337Model 239386Model 239943Model 240269Model 240633Model 240705Model 240903Model 240904Model 241034Model 241223Model 241224Model 241313.Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
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.