Bayer Source Administration Set Recall: Black Specks on Needles

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Contact the company & request your remedy

Recalling firmBayer Medical Care, Inc.1 Bayer Dr · Indianola, PA 15051-9702

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Bayer is recalling Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System because black specks may be present on the needles. This could potentially affect the accuracy of radiopharmaceutical delivery during PET scans.

Why it’s dangerous

Black specks on the needles could potentially interfere with the accurate delivery of radiopharmaceuticals during PET scans. This might lead to incorrect dosing of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) in patients.

Who’s affected

Healthcare professionals using the Source Administration Set with Medrad Intego PET Infusion System for PET scans. Patients receiving radiopharmaceuticals during these procedures are at minimal risk.

How to tell if you have this one

Check for the sterile catalog number INT CSS on the Source Administration Set. The affected batch number is 60272154, with an expiration date of December 9, 2023.

Brand
Bayer Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Black Specks
Inspect the needles for black specks. If present, stop using the set immediately.

✎ GovInfoNow

Questions people ask

What is the product being recalled?

The Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, with sterile catalog number INT CSS.

What is the hazard?

Black specks may be present on the needles, which could affect the accuracy of radiopharmaceutical delivery during PET scans.

What should I do if I have the recalled product?

Inspect the needles for black specks. If present, stop using the set immediately.

Take action

Contact Bayer Medical Care

We’ve drafted a message you can send Bayer Medical Care to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0910-2023 — Bayer Medical Care Bayer Medical Care

Hello,

I own a Bayer Medical Care that is covered by recall Z-0910-2023 from Bayer Medical Care.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0910-2023 (November 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0910-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Bayer Medical Care, Inc. recalls Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS

Lower-risk recall