CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled
Radiometer Medical ApS is recalling Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80, distributed nationwide in the US. The recall was initiated on 8 Apr 2022 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-1115-2022
- FDA event ID
- 90093
- Recalling firm
- Radiometer Medical ApS, Bronshoj, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2022
- FDA classified
- 19 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2022 | Recall initiated by company | |
| 19 May 2022 | Classified by FDA | +41 days |
| 25 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria, Algeria, Argentina, Bolivia, Bosnia, Brazil, Burkina, Faso, Chile, Colombia, Cyprus, Ecuador, Egypt, Eswatin, Ethiopia, Greece, Guatemala, Israel, Lebanon, Libya, Lithuania, Malawi, Nicaragua, Romania, Senegal, Serbia, Slovenia, Thailand, Uganda, Uruguay, Vietnam, Zimbabwe, Belgium, Netherlands, China, Macao, Croatia, Hungary, Denmark, Iceland, Germany, Spain, Portugal, India, Japan, United Kingdom, Ireland, Russia, Australia, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Georgia, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong.
Nationwide ArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNew MexicoNew York
Questions about this recall
Why was it recalled?
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Which lots are affected?
"All Lots" UDI/DI: 05700699565525
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria, Algeria, Argentina, Bolivia, Bosnia, Brazil, Burkina, Faso, Chile, Colombia, Cyprus, Ecuador, Egypt, Eswatin, Ethiopia, Greece, Guatemala, Israel, Lebanon, Libya, Lithuania, Malawi, Nicaragua, Romania, Senegal, Serbia, Slovenia, Thailand, Uganda, Uruguay, Vietnam, Zimbabwe, Belgium, Netherlands, China, Macao, Croatia, Hungary, Denmark, Iceland, Germany, Spain, Portugal, India, Japan, United Kingdom, Ireland, Russia, Australia, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Georgia, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong.
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.
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 ABL90 Flex Plus Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
| Device | CLASS II | Radiometer ABL90 FLEX Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |