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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90924

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

Open FDA event record

Event summary

Timeline bucket
September 20, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Angiodynamics, 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

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

Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT

Z-0132-2023
Recall number
Z-0132-2023
Initiated
September 20, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Angiodynamics, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

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

Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

Code information

UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025

Distribution pattern

US Nationwide distribution in the states of AZ, CA, DC, IN, PA.