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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92906

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Fresenius Medical Care Holdings, Inc.

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

3 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 3

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Z-0005-2024
Recall number
Z-0005-2024
Initiated
August 08, 2023
Classification
Class I
Status
Ongoing
Quantity
124,773 boxes total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for blood backfill leakage and foreign material.

Code information

UDI-DI: 16945060501122; All Lots

Distribution pattern

US Nationwide.

device · product 2 of 3

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Z-0006-2024
Recall number
Z-0006-2024
Initiated
August 08, 2023
Classification
Class I
Status
Ongoing
Quantity
124,773 boxes total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for blood backfill leakage and foreign material.

Code information

UDI-DI: 16945060500125; All Lots

Distribution pattern

US Nationwide.

device · product 3 of 3

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

Z-0007-2024
Recall number
Z-0007-2024
Initiated
August 08, 2023
Classification
Class I
Status
Ongoing
Quantity
124,773 boxes total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for blood backfill leakage and foreign material.

Code information

UDI-DI: 16945060500101; All Lots

Distribution pattern

US Nationwide.