Sterilmed, Inc.NLHClass II

Catheter, Recording, Electrode, Reprocessed

Sterilmed, Inc.'s record for this product code

MDR events69All time

Recalls1All time

510(k) clearances10All time

Recent MDR events

69 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedJan 13, 2009
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
View FDA record ↗

510(k) clearances

10 clearances for this product code