FJPClass II

Adaptor, Y

Gastroenterology, Urology · 21 CFR 876.5820

MDR events4All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances0All time

Recent MDR events

4 adverse event reports on file

Event type breakdown

Injury4

Most-reported manufacturers

Stryker Orthopaedics Limerick3 B.braun1

Recalls

1 recall events for this product code

Isopure Corp
TerminatedOct 11, 2011
Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 510510
Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.
Z-0033-2012 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.