Radiometer Medical ApS Akandevej 21 Bronshoj Denmark 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; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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;
Brand
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
Lot Codes / Batch Numbers
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
Products Sold
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;
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark is recalling PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial due to Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 03/26/2021, the firm initially sent an "Urgent: Medical Device Recall" Notification Letter via email and followed up with a hardcopy via FedEx. The Notification Letter informed customers that the Recalling Firm had become aware of an issue related to the sterile barrier system for its arterial blood sampler product. The potential risks associated with the affected products could potentially be bacterial bloodstream infection with immunosuppressed patients being at particular risk. Customers are instructed to: 1) Check their inventory of the affected Arterial Blood Samplers 2) Check for the affected Arterial Blood Samplers that were distributed within their institution. 3) Collect any of the affected Arterial Blood Samplers 4) Complete the Recall Response Form (last page of this letter) and return to the fax number listed on the form. 5) For U.S. Customer return affected Arterial Blood Samplers to: Radiometer America 810 Sharon Drive Westlake, OH, 44145 Attn: RGA (ID) Any questions, contact 1-800-736-0600 option 1, Monday - Friday 9am to 7pm (EST).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026