Overview of recall records associated with TZ Medical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 3.
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
This page summarizes recall records in which the official source identifies TZ Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
