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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91560

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cardinal Health 200, LLC

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

Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B

Z-1157-2023
Recall number
Z-1157-2023
Initiated
November 18, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
4560 EA

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Code information

UDI-DI: 50195594577153(cs) 10195594577155(ea) Lot Number: 816643 Exp. Date: 2/1/2025

Distribution pattern

US Nationwide distribution in the states of GA, PA.

device · product 2 of 3

Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A

Z-1158-2023
Recall number
Z-1158-2023
Initiated
November 18, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
36 EA

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Code information

UDI-DI: 50195594381965(cs) 10195594381967(ea) Lot Number: 706265 Exp. Date: 5/1/2024

Distribution pattern

US Nationwide distribution in the states of GA, PA.

device · product 3 of 3

Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E

Z-1159-2023
Recall number
Z-1159-2023
Initiated
November 18, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
31,300 EA

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Code information

UDI-DI: 50195594389336(ea) 10195594389338(cs) Lot Number: 818636 Exp. Date: 3/1/2024

Distribution pattern

US Nationwide distribution in the states of GA, PA.