# FDA recall Z-1115-2022

> **Radiometer Medical ApS** · Class II · device recall initiated 2022-04-08.

## Product

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

## Reason for recall

Arterial Blood Sampler  sterility cannot be guaranteed throughout the shelf life of the product.

## Distribution

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.

## Key facts

- **Recall number:** Z-1115-2022
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-08
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1115-2022

## Citation

> AI Analytics. FDA recall Z-1115-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1115-2022. Source: US FDA. Licensed CC0.

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