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Spectra
UZINMEDICARE CO.,LTD · Model Spectra Handy Plus · UDI-DI 08809108019097
10
510(k) clearances
82
Adverse events
2
Recalls
92
Facilities
Description
A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-02-12 | Ameda, Inc. | Devices were not sterilized |
| 2015-02-12 | Ameda, Inc. | Devices were not sterilized |
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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.