Z-0910-2023Class II

Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT...

Name: Z-0910-2023 Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT...
Creator: Bayer Medical Care, Inc.
Published: 2022-11-30
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2022-11-30 / Open, Classified / root cause: packaging

FDA source

Bayer Medical Care, Inc. began a recall of Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to... on 2022-11-30. FDA classified it as Class II and gives the reason as "Black specks may be present on the packaged needles". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0910-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-30
Posted: 2023-01-06
Recalling firm: Medrad, Inc.
Product: Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.
Product code: FRN Pump, Infusion
Reason for recall: Black specks may be present on the packaged needles
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Bayer US issued Urgent Medical Device Recall (RECALL ID: SA-22-RAD-05 ) Letter on 11/30/22 via email. Letter states reason for recall, health risk and action to take: 1. Review your current inventory for affected Lot 60272154 and quarantine, as appropriate. 2. Complete the included response form and submit through email to [email protected] or contact our Bayer Customer Service team at 1-800-633-7231, Press 0, then option 3. Please complete the Customer Response Form regardless of whether you have affected product or not. This action will assist us in tracking all impacted product. 3. You will receive a Return Goods Authorization (RGA) number to return any affected kits remaining in your inventory for a credit. 4. Place the affected product in a box and label the outside of the container with the RGA number in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return affected product as soon as possible 5. Upon Bayer receipt of returned product, you will receive a credit on your account. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.
Quantity in commerce: 2840 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Product codes and lots: UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0910-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0910-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code FRN

K100798Class IIMedrad Intego Pet Infusion System, Source Administration Set, Patient Adminstratin Set Model Int Sys 100, Int Css, Int CMedrad, Inc. / cleared 2010-06-23

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)