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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:114944

STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.

Official recall number

Z-0661-2013

Evidence summary

Product code
MLR
Recall status
Terminated
Event initiated
September 20, 2012
Root cause
Labeling design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0661-2013