FDA Device recall Z-1571-2021
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-…
- FDA Device
- Class II
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-… 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-1571-2021 |
| 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 CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets 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: CL3028T UDI: (01) 1 0887709 09996 5 (17) 260101 (30) 50 (10) 5125199 Lot Number: 5125199 |
|---|
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-1571-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.