Medrad — Class II medical device recall Z-0603-2013
Terminated recall by Medrad Inc, reported 2012-12-26, distributed nationwide. Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore)
| Recall number | Z-0603-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medrad Inc, Indianola, PA, United States |
| Recall initiated | 2012-04-18 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2015-08-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, DE, DK, DO, EE, FI, FR, GB, HK, IL, IN, IT, JP, KR, LB, MX, MY, PL, PT, SE, SG, TH, TW |
| Quantity | 1,229 pumps |
Product
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
Reason for recall
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
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-0603-2013. 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.