CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS
Radiometer Medical ApS is recalling safeCLINITUBES Blood Sampler, distributed in 38 states. The recall was initiated on 17 Mar 2020 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-2247-2020
- FDA event ID
- 85478
- Recalling firm
- Radiometer Medical ApS, Bronshoj, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2020
- FDA classified
- 2 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Mar 2020 | Recall initiated by company | |
| 2 Jun 2020 | Classified by FDA | +77 days |
| 10 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Product as listed by the FDA
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Where it was distributed
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, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.
AlaskaAlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Which lots are affected?
Lot numbers:R2425 - R2524
Where was it sold?
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, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.
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.
Other products in this recall event
2 other products · FDA event 85478This product is part of a recall event; the main page for the event is safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | 38 states | |
| CLASS II | safeCLINITUBES Blood Sampler recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | 38 states |
More recalls from Radiometer Medical ApS
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled | Radiometer Medical ApS | Device Malfunction | 49 states |
| Device | CLASS II | Aqure REF 933-599 Software Versions 2.5.2 recalled | Radiometer Medical ApS | Packaging Defects | Nationwide |
| Device | CLASS II | ABL800 Flex Analyzer recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | Nationwide |
| Device | CLASS II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled | Radiometer Medical ApS | Sterility | Nationwide |
| Device | CLASS II | Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |