Z-1115-2022Class II

Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for...

Name: Z-1115-2022 Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for...
Creator: Radiometer Medical ApS
Published: 2022-04-08
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2022-04-08 / Open, Classified / root cause: packaging

FDA source

Radiometer Medical ApS began a recall of 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 on 2022-04-08. FDA classified it as Class II and gives the reason as "Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1115-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-08
Posted: 2022-05-19
Recalling firm: Radiometer Medical ApS
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On April 26, 2022 Radiometer issued a "Urgent Medical Device Recall" notification via Email. The firm ask consignees to take the following actions: Radiometer kindly request you to stop using the affected product with immediate effect. To ensure patient safety in your facility, kindly follow the steps below: " Check your inventory of the above PICO50 Arterial Blood Samplers " Check for the above PICO50 Arterial Blood Samplers distributed in your institution. " Collect any of the above PICO50 Arterial Blood Samplers and put on quarantine " Complete the Recall Response Form (last page of this letter) and return to your Radiometer representative together with the quarantined PICO50 Arterial Blood Samplers. To ensure you receive credit for the PICO50 Arterial Blood Samplers, please contact Customer Service @ [email protected] to receive a Return Goods Authorization
Quantity in commerce: 7,228 boxes (100 units per box)
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.
Product codes and lots: "All Lots" UDI/DI: 05700699565525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1115-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1115-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-19

Product code JKA

K962158Class IIPico Models 30, 50, 70Radiometer America, Inc. / cleared 1996-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)