Medrad Source Administration Sets — Class II medical device recall Z-0627-2016
Terminated recall by Bayer Healthcare, reported 2016-01-20, distributed nationwide. The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of
| Recall number | Z-0627-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2015-11-30 |
| Classified | 2016-01-11 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 198,598 |
| Reason classes | specification failure |
Product
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Reason for recall
The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail
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-0627-2016. 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.