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Isolite, i3
ZYRIS, INC. · Model PIL0306 · UDI-DI 00810032660802
3
510(k) clearances
5
Adverse events
3
Recalls
73
Facilities
Description
Vacuum Lever Set, i3
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-04-13 | Busse Hospital Disposables | Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl |
| 2004-04-13 | Busse Hospital Disposables | Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl |
| 2004-04-13 | Busse Hospital Disposables | Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a sl |
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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.