FDA Device recall Z-0747-2024
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R by Smiths Medical Asd, citing there is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0747-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-10 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Reason
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices 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.
Identifiers
| code_info | Lot Number: 4383431 4387987 4404698 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0747-2024%22
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