Z-0927-2017Class II

MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium...

Name: Z-0927-2017 MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium...
Creator: Bayer Healthcare
Published: 2016-11-07
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2016-11-07 / Terminated

FDA source

Bayer Healthcare began a recall of MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to... on 2016-11-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0927-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2017-02-08
Terminated: 2017-10-18
Recalling firm: Medrad, Inc.
Product: 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.
Product code: FRN Pump, Infusion
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.
FDA root cause: Under Investigation by firm
Action: Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, opt 2. For questions regarding this recall call 412-767-2400. On December 5, 2016, the recalling firm sent a new letter indicating the inline filter has been successfully tested and that they have qualified a compatible in-line filter to be used with the Patient Administrative Set (PAS) that will allow you to resume use of your Intego system.
Quantity in commerce: 178,982 (86,172 units in U.S.)
Distribution: Nationwide Distribution
Product codes and lots: Device Listing # D053816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0927-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-07

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)