FDA Device recall Z-1343-2018
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches…
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches… by Icu Medical, citing the infusion sets were manufactured with an incorrect spin collar.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1343-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-05 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which 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
The infusion sets were manufactured with an incorrect spin collar.
Identifiers
| code_info | Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0…Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1343-2018%22
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