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EL3 LED
Heine Optotechnik GmbH & Co. KG · Model 000 · UDI-DI 04053755199754
10
510(k) clearances
801
Adverse events (2 deaths)
3
Recalls
120
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-16 | Cardinal Health Inc. | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| 2015-11-20 | Bigwall Enterprises | "The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investi |
| 2003-04-15 | KAZ Inc. | Humidifiers may overheat. |
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