Class II — Radiometer Medical ApS
| Recalling firm | RADIOMETER MEDICAL APS |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. |
| Product | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 |
| Quantity | 5 units |
| Distribution | U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Li… |
| Initiated | 2020-03-17 |
| Classified | 2020-06-02 |
| Terminated | 2022-07-28 |
| Recall number | Z-2249-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Radiometer Medical ApS (Z-2249-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85478/
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