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Class 2 Device Recall safeCLINITUBES |
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Date Initiated by Firm |
March 17, 2020 |
Create Date |
June 03, 2020 |
Recall Status1 |
Terminated 3 on July 28, 2022 |
Recall Number |
Z-2248-2020 |
Recall Event ID |
85478 |
Product Classification |
Tube, collection, capillary blood - Product Code GIO
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Product |
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 |
Code Information |
Lot numbers: R1431 - R1495 |
Recalling Firm/ Manufacturer |
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
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Manufacturer Reason for Recall |
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
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FDA Determined Cause 2 |
Process control |
Action |
The method of notification of the recall was a customer letter sent to all consignees via email and a hard copy sent via FedEx 2nd day with tracking and proof of delivery; date of issue was 3/17/20.
Customers were instructed to do the following with the recalled product:
-Cease using the Blood Samplers from the affected lots.
-Check inventory of Blood Samplers from the affected lots.
-Check for Blood Samplers from the affected lots distributed in the institution.
-Collect any Blood Samplers from the affected lots.
-Complete the Recall Response Form (last page of the customer advisory letter) and return it to the representative.
-Discard the collected Blood Samplers of the affected lots.
For any questions contact at 1-800-736-0600 option 1, Monday-Friday, 9am EST to 7pm EST. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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