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Amvex Vacuum Regulator
OHIO MEDICAL, LLC · Model C2L · UDI-DI 00628101501129
KDP
Prescription
10
510(k) clearances
99
Adverse events (6 deaths)
4
Recalls
29
Facilities
Description
VR-C2 series, VacReg, Cont 2Mode 300mmHg, Analog Dual (mmHg &kPa)
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.