Container, Empty, For Collection & Processing Of Blood & Blood Components
FDA adverse event reports and recall history for container, empty, for collection & processing of blood & blood components (product code KSR), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 615
- Deaths
- 8
- Injuries
- 27
- Malfunctions
- 526
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2012-04-12TerminatedNonconforming Material/Component
DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
Device's needle may become dislodged from the cup during shipment or during use.
- 2012-04-12TerminatedNonconforming Material/Component
DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
Device's needle may become dislodged from the cup during shipment or during use.
- 2006-09-09TerminatedOther
BD Direct Draw Adapters, Catalog Number 364896.
Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
- 2006-01-11TerminatedOther
BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder.
Cracked finger grip luer adapter components on the Push Button Blood Collection Set.
Monitor container, empty, for collection & processing of blood & blood components automatically
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