FDA Device recall Z-1566-2021
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patien…
- FDA Device
- Class II
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patien… 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-1566-2021 |
| 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 CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
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: CH3582 UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197 Lot Number: 5125197 |
|---|
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-1566-2021%22
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