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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94313

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

Open FDA event record

Event summary

Timeline bucket
March 12, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

2 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 2

namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

Z-1806-2024
Recall number
Z-1806-2024
Initiated
March 12, 2024
Classification
Class II
Status
Ongoing
Quantity
570 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

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

Products have a lack of sterility assurance.

Code information

a) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI

Distribution pattern

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

device · product 2 of 2

Namic FLUID DELIVERY SET, REF 91300040

Z-1807-2024
Recall number
Z-1807-2024
Initiated
March 12, 2024
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

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

Products have a lack of sterility assurance.

Code information

UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381

Distribution pattern

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.