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InfuseIT
SALTER LABS · Model ZIT-502 · UDI-DI 00607411913402
KZD
Prescription
10
510(k) clearances
508
Adverse events (15 deaths)
14
Recalls
83
Facilities
Description
InfuseIT 500 ml Disposable Pressure Infusor
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.