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Deltaven Fast Flash

DELTA MED SPA · Model 3820673 · UDI-DI 08032248382060

FOZ Prescription
10
510(k) clearances
48,998
Adverse events (141 deaths)
394
Recalls
198
Facilities

Description

Safety IV catheter in PUR with closed system, double entry with needleless valve

Recalls

DateFirmReason
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-05-21Becton Dickinson Infusion Therapy Systems, Inc.Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21Becton Dickinson Infusion Therapy Systems, Inc.Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21Becton Dickinson Infusion Therapy Systems, Inc.Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
2025-05-21Becton Dickinson Infusion Therapy Systems, Inc.Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

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Data 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.