LZFClass II

Pump, Infusion, Analytical Sampling

General Hospital · 21 CFR 880.5725

MDR events2All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances7All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Death1

Malfunction1

Most-reported manufacturers

Covidien1 Via Medical Corp.1

Recalls

1 recall events for this product code

International Biomedical, Ltd.
TerminatedJun 11, 2013
VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The c
International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to
Z-1531-2013 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

7 clearances for this product code