Terminated

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;

FDA Recall Z-1683-2021 · Posted None

Recalling FirmRadiometer Medical ApS

Recall StatusTerminated

Product CodeJKA

Date Initiated2021-03-26

Date Terminated2023-03-01

Product Quantity348,178 boxes worldwide (1,883 boxes in the U.S.)

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.

Firm Action

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).

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.