Source Administration Set — Class II medical device recall Z-0910-2023
Ongoing recall by Bayer Medical Care, Inc., reported 2023-01-18, distributed nationwide. Black specks may be present on the packaged needles
| Recall number | Z-0910-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Medical Care, Inc., Indianola, PA, United States |
| Recall initiated | 2022-11-30 |
| Classified | 2023-01-06 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN |
| Quantity | 2,840 units |
| UPC / GTIN / UDI-DI | 00616258021478 |
| Lot numbers | 60272154 |
| Expiration dates | 2023-12-09 |
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.
Reason for recall
Black specks may be present on the packaged needles
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0910-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.