Smiths Medical Asd Inc Recall 93506
Description: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Smiths Medical Asd Inc Recall 93506 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0747-2024 |
| Event ID | 93506 |
| Event Description | 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, UAE. |
| Quantity | 31,685 total |
| Recall Reason | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device s O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication. |
| Device Classification | 20240124 |
| Device Code Info | Lot Number: 4383431 4387987 4404698 |
| Center Classification Date | 20240117 |
| Recall Initiation Date | 20231110 |
| Recalling Firm | Smiths Medical Asd Inc |
| Initial Notification | Letter |
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