FDA (Devices) recall action 84332
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Routine sterilization dose does not meet the required Sterility Assurance Level.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic Xomed is recalling Lamicel 20PK 5MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.
Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.
Medtronic Xomed is recalling Lamicel 10PK 10MM INTL sponges because the routine sterilization dose does not meet the required Sterility Assurance Level.