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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96066

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

Open FDA event record

Event summary

Timeline bucket
December 23, 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

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.

Z-1048-2025
Recall number
Z-1048-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Quantity
1200 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Code information

UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990

Distribution pattern

US: FL, KS, ND, PA, WA, WV, IL, WA

device · product 2 of 2

MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.

Z-1049-2025
Recall number
Z-1049-2025
Initiated
December 23, 2024
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Code information

UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420

Distribution pattern

US: FL, KS, ND, PA, WA, WV, IL, WA