Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection.
Summary
The FDA issued a Class II for Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrol by Radiometer Medical ApS. Reason: Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product..
Details
Source
Device Recall
External ID
Z-1115-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: "All Lots" UDI/DI: 05700699565525
Quantity Affected: 7,228 boxes (100 units per box)
Reason for Recall
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-08
Company
Bronshoj, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Radiometer Medical ApS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Radiometer Medical ApS have FDA actions?
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1115-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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