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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95748

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Greiner Bio-One GmbH

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

VACUETTE SAFELINK, REF: 450210

Z-0802-2025
Recall number
Z-0802-2025
Initiated
November 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Greiner Bio-One GmbH
Quantity
188,800 pcs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

Code information

UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215

Distribution pattern

US Nationwide distribution in the states of IL, PA.