CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report

Medrad Intego PET Infusion System recalled by Bayer Healthcare

Bayer Healthcare is recalling Medrad Intego PET Infusion System - Pump Intended to deliver accurate doses of, distributed nationwide in the US. The recall was initiated on 7 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Listing # D053816

Quantity recalled178,982 (86,172 units in U.S.)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0927-2017
FDA event ID: 75736
Recalling firm: Bayer Healthcare, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 7 Nov 2016
FDA classified: 7 Feb 2017
Reported: 15 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Insulin Pumps & Glucose Monitors

Timeline

7 Nov 2016	Recall initiated by company
7 Feb 2017	Classified by FDA	+92 days
15 Feb 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Device Listing # D053816

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Bayer Healthcare

All 11

Reported	Class	Recall	Company	Reason	Where
23 Nov 2016Device	CLASS II	PET Infusion Pump recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
14 Sep 2016Device	CLASS II	Certegra Workstation used in conjunction recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
27 Jul 2016Device	CLASS II	Angiographic Injector and Syringe recalled by Bayer Healthcare	Bayer Healthcare	Other	NY
20 Jan 2016Device	CLASS II	Medrad Source Administration Sets recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
23 Sep 2015Device	CLASS II	Angiographic Injector recalled by Bayer Healthcare	Bayer Healthcare	Device Malfunction	Nationwide

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