Lower riskMedical device recall · FDA · Published November 30, 2022
Bayer Source Administration Set Recall: Black Specks on Needles
Bayer recalls Source Administration Sets (SAS) used with Medrad Intego PET Infusion System due to potential black specks on needles. These specks may affect radiopharmaceutical delivery during PET scans.
“Bayer Source Administration Set Recall: Black Specks on Needles.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59265-bayer-source-administration-set-recall-black-specks-on-needles. Based on FDA recall #Z-0910-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0910-2023%22&limit=1).
Bayer Medical Care, Inc. recalled Source Administration Sets used with the Medrad Intego PET Infusion System due to black specks on packaged needles, according to the FDA. The agency announced the voluntary Class II recall on November 30, 2022.
How to tell if you have it
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS
UPC 00616258021478
Batch number: 60272154
Expiration date: December 9, 2023
The hazard
The recall addresses the risk of black specks being present on the packaged needles. The Source Administration Sets are intended to deliver accurate doses of radiopharmaceuticals during molecular imaging diagnostic procedures.
Context
GovInfoNow's records show Bayer Medical Care, Inc. has 7 other recalls on record since June 28, 2018. Other recent recalls include the Bayer Stellant FLEX Syringe Kit Recall for sterilization issues (July 31, 2026) and the Bayer Avanta Tube Sets recall for stopcock disengagement risk (April 24, 2026). Similar product recalls include the B Braun Blood Administration Sets recall for medication backflow risk (October 29, 2025) and the ICU Medical Plum Administration Sets recall for black specks in drip chambers (May 12, 2026).
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
Product
Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Indiana, Minnesota, New York, Ohio, Texas, Virginia.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.