Smiths Medical ASD Inc. Recall 87647
Description: Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
Smiths Medical ASD Inc. Recall 87647 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1480-2021 |
| Event ID | 87647 |
| Event Description | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer. |
| Product Type | Devices |
| Distribution | Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. |
| Quantity | 11340 units |
| Recall Reason | Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices. |
| Device Classification | 20210428 |
| Device Code Info | a. REF 601280, Lot Numbers: 3872300, 3946984 b. REF 601281, Lot Numbers: 3872301, 4024481 |
| Center Classification Date | 20210421 |
| Recall Initiation Date | 20210331 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | |
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