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automatic pressure infusor
Biegler GmbH · Model autopress · UDI-DI 09008247000600
10
510(k) clearances
508
Adverse events (15 deaths)
14
Recalls
83
Facilities
Description
The automatic pressure infusor autopress is used when liquids are to be supplied under constant pressure.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-05-22 | 3M Company - Health Care Business | It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification. |
| 2011-03-04 | GE Healthcare, LLC | Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate. |
| 2009-09-29 | Merit Medical Systems, Inc. | Potential sterility breach caused by excessive shipment damage. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
| 2008-09-20 | CAS Medical Systems, Inc. | Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056. |
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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.