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U.S. Department of Health and Human Services

Class 2 Device Recall PICO70 Arterial Blood Sampler

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  Class 2 Device Recall PICO70 Arterial Blood Sampler see related information
Date Initiated by Firm March 26, 2021
Create Date May 26, 2021
Recall Status1 Terminated 3 on March 01, 2023
Recall Number Z-1683-2021
Recall Event ID 87867
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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;
Code Information 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;  
Recalling Firm/
Manufacturer		 Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
For Additional Information Contact Technical Support, Radiometer America Inc.
800-736-0600 Ext. 1
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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).
Quantity in Commerce 348,178 boxes worldwide (1,883 boxes in the U.S.)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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