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MediEvac+
GCE, s.r.o. · Model 0735101US · UDI-DI 08592346755017
10
510(k) clearances
99
Adverse events (6 deaths)
4
Recalls
29
Facilities
Description
MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation. MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc. The product is not intended to be powered from: • a venturi vacuum source • a pressure gas source. The product is not intended for: • field use • direct use during thoracic drainage
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-12 | Ohio Medical Corporation | Final quality control testing was not completed before the devices were distributed.. |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
| 2005-08-01 | Boehringer Laboratories, Inc. | Condition exists that prevents complete shutoff of the valve |
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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.