CLASS II Device recall · Reported 2 Jun 2021 · FDA Enforcement Report

956-518 PICO70 w/o needle recalled by Radiometer Medical ApS

Radiometer Medical ApS is recalling 956-518 PICO70 w/o needle, distributed nationwide in the US. The recall was initiated on 26 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: PICO70, Arterial blood sampler without needle: 956-518; 956-519; PICO70, Arterial blood sampler with needle: 956-522; 956-525; 956-529; 956-533; 956-534; 956-547;

Quantity recalled348,178 boxes worldwide (1,883 boxes in the U.S.)

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-1683-2021
FDA event ID: 87867
Recalling firm: Radiometer Medical ApS, Bronshoj, N/A
Classification: Class II
Status: Terminated
Recall initiated: 26 Mar 2021
FDA classified: 26 May 2021
Reported: 2 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Patient Monitors

Timeline

26 Mar 2021	Recall initiated by company
26 May 2021	Classified by FDA	+61 days
2 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.

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

PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, IL, LA, MA, MI, MO, MT, NJ, NY, OK, PA, TX, WA, and WI. The countries of Australia, New Zealand, Canada, Algeria, Bahrain, Belarus, Bosnia and Herzegovina, Colombia, Costa Rica, Ethiopia, Greece, Guatemala, Indonesia, Lebanon, Lithuania, Malawi, Mali, Oman, Peru, Romania, Saudi Arabia, Senegal, Uganda, United Arab Emirates, Austria, Belgium, Netherlands, Luxembourg, China, Taiwan, Croatia, Czech Republic, Slovakia, Denmark, Faroe Islands, Iceland, Finland, France, Germany, Hungary, India, Maldives, Italy, Japan, Kazakhstan, Mexico, Norway, Poland, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, Georgia, and United Kingdom.

Nationwide California Colorado Florida Georgia Illinois Louisiana Massachusetts Michigan Missouri Montana New Jersey New York Oklahoma Pennsylvania Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers: PICO70, Arterial blood sampler without needle: 956-518; 956-519; PICO70, Arterial blood sampler with needle: 956-522; 956-525; 956-529; 956-533; 956-534; 956-547;

Where was it sold?

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.

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