Recall Z-0103-2022
Smiths Medical ASD Inc. · initiated March 10, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Codes / lots: All codes
Reason for recall
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0103-2022
- Initiated
- March 10, 2020
- Terminated
- September 22, 2023
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Quantity
- 3620 units
- Distribution
- Austria, France, Germany, Great Britain, and Saudi Arabia
- Recalling firm
- Smiths Medical ASD Inc., Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0092-2022 Class II | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b)…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0093-2022 Class II | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0094-2022 Class II | smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0095-2022 Class II | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0096-2022 Class II | smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0097-2022 Class II | smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0098-2022 Class II | smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number…Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0099-2022 Class II | smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0100-2022 Class II | smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0101-2022 Class II | smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |
| Z-0102-2022 Class II | smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. | 03/10/2020Terminated |