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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95152

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

Open FDA event record

Event summary

Timeline bucket
July 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Perfusion Systems

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

Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312

Z-3128-2024
Recall number
Z-3128-2024
Initiated
July 09, 2024
Classification
Class II
Status
Ongoing
Quantity
290 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).

Code information

GTIN 20613994879329, Lot Numbers: 2023090954, 202312C065

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.