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Corporation Steris Canada · Model FD257 · UDI-DI 00724995176730
10
510(k) clearances
264
Adverse events
1
Recalls
29
Facilities
Description
The RAS 12 Long Rack is designed to enable the mechanical cleaning, rinsing, and disinfection of up to 12 robotic-assisted surgery instruments in the AMSCO 7052HP and or 7053HP Single Chamber Washer Disinfectors.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-05-06 | Custom Ultrasonics, Inc. | To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.