FDA Device recall Z-0018-2025
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 by Smiths Medical Asd, citing certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0018-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-26 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Reason
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Identifiers
| code_info | UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB |
|---|
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-0018-2025%22
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