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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75736

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

Open FDA event record

Event summary

Timeline bucket
November 07, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bayer Healthcare

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

MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.

Z-0927-2017
Recall number
Z-0927-2017
Initiated
November 07, 2016
Classification
Class II
Status
Terminated
Recalling firm
Bayer Healthcare
Quantity
178,982 (86,172 units in U.S.)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulates

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

Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted.

Code information

Device Listing # D053816

Distribution pattern

Nationwide Distribution