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Recall Observatory FDA recall evidence

Device product

safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

Z-2248-2020

March 17, 2020

Class II

Product summary

Firm
Radiometer Medical ApS
Event
Event 85478
Status
Terminated
Classification
Class II
Quantity
269 units
Official record key
device-enforcement:Z-2248-2020

Official wording

Reason: The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

Code information: Lot numbers: R1431 - R1495

Distribution pattern: U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.