Home › Cole Instruments Inc › mini Powered Cole Isolation Device
mini Powered Cole Isolation Device
Cole Instruments Inc · Model mPCID · UDI-DI 00810072351005
3
510(k) clearances
4,301
Adverse events
6
Recalls
47
Facilities
Description
mini Powered Cole Isolation Device (mPCID). Sterilize handpiece before first use and before each use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-23 | Pro-Dex Inc | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package. |
| 2016-01-15 | The Anspach Effort, Inc. | The device is reported to enter safe mode and is no longer able to charge batteries. |
| 2015-12-23 | Pro-Dex Inc | The sterile battery may contain particulates within the sterile package. |
| 2015-12-23 | Pro-Dex Inc | The sterile battery may contain particulates within the sterile package. |
| 2015-11-25 | The Anspach Effort, Inc. | Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON". |
| 2006-09-28 | Lumiport, LLC | Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device. |
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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.