Date Initiated by Firm |
March 10, 2020 |
Create Date |
October 13, 2021 |
Recall Status1 |
Terminated 3 on September 22, 2023 |
Recall Number |
Z-0094-2022 |
Recall Event ID |
88667 |
Product Classification |
Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
|
Product |
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 |
Code Information |
All codes |
Recalling Firm/ Manufacturer |
Smiths Medical ASD Inc. 6000 Nathan Ln N Minneapolis MN 55442-1690
|
For Additional Information Contact |
Dave Halverson 763-383-3310
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Manufacturer Reason for Recall |
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
The firm initiated the recall by letter during the week of 03/10/2020. The notices requested the direct consignee notify their customers and collect the responses. The firm is seeking return of the products. |
Quantity in Commerce |
3100 units |
Distribution |
Austria, France, Germany, Great Britain, and Saudi Arabia |
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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