FDA Device recall Z-1574-2021
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros
- FDA Device
- Class II
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros by Icu Medical, citing due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1574-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-16 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Identifiers
| code_info | REF: CL3960 UDI: (01) 1 0557709 08327 (17) 260101 (30) 50 (10) 5125262 Lot Number: 5125262 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2021%22
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