FDA Device Intelligence
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Infusor, Pressure, For I.V. Bags

FDA product code KZD · Class 1 · General Hospital

375
Registered devices
508
Adverse events
14
Recalls
35
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-05-223M Company - Health Care BusinessIt was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specificati
2011-03-04GE Healthcare, LLCInfusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequ
2009-09-29Merit Medical Systems, Inc.Potential sterility breach caused by excessive shipment damage.
2008-09-20CAS 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
2008-09-20CAS 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
2008-09-20CAS 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
2008-09-20CAS 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
2008-09-20CAS 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
2008-09-20CAS 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
2008-09-20CAS 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.