FDA Device recall Z-1347-2018
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Ster…
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Ster… 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-1347-2018 |
| 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
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, 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 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892…Lot number 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493; lot number 3498769, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769; and lot number 3498773, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773. |
|---|
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-1347-2018%22
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