PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 10, 2020 Initiated: March 17, 2020 #Z-2248-2020

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Radiometer Medical ApS
Units Affected
269 units
Distribution
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.
Location
Bronshoj, N/A

Frequently Asked Questions

What product was recalled?
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1. Recalled by Radiometer Medical ApS. Units affected: 269 units.
Why was this product recalled?
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2248-2020.