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/AEMS corpus and the live FDA recall database.
- Total reports
- 614
- Deaths
- 8
- Injuries
- 27
- Malfunctions
- 525
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition 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
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.