Date Initiated by Firm | March 10, 2020 |
Create Date | October 13, 2021 |
Recall Status1 |
Terminated 3 on September 22, 2023 |
Recall Number | Z-0095-2022 |
Recall Event ID |
88667 |
Product Classification |
Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
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Product | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081 |
Code Information |
All codes |
Recalling Firm/ Manufacturer |
Smiths Medical ASD Inc. 6000 Nathan Ln N Minneapolis MN 55442-1690
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For Additional Information Contact | Dave Halverson 763-383-3310 |
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 | 10620 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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