Recall Z-0092-2022 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Smiths Medical ASD Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
| Date | Mar 10, 2020 |
| Status | Terminated |
| Reason | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| Root cause | 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 | 17980 units |
| Distribution | Austria, France, Germany, Great Britain, and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.