CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
Source Administration Set (SAS) used recalled by Bayer Medical Care
Bayer Medical Care is recalling Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile, distributed nationwide in the US. The recall was initiated on 30 Nov 2022 and the FDA has classified it as Class II.
Check your package
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-0910-2023
- FDA event ID
- 91273
- Recalling firm
- Bayer Medical Care, Indianola, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Nov 2022
- FDA classified
- 6 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 30 Nov 2022 | Recall initiated by company | |
| 6 Jan 2023 | Classified by FDA | +37 days |
| 18 Jan 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Black specks may be present on the packaged needles
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
Questions about this recall
Why was it recalled?
Black specks may be present on the packaged needles
Which lots are affected?
UDI: (01)00616258021478(11)201209(17)231209(10)60272154 Batch number: 60272154 Expiration date: December 9, 2023
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, IN, MN, NY, OH, TX, VA and the country of China.
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.
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