FDA Device recall Z-0678-2014
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item…
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item… by Icu Medical, citing ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-24 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Icu Medical |
| Distribution | AL, CA, GA, HI, IL, IN, KY, NC, NH, OH, TN, TX, UT, VT, WI |
Product
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Reason
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
Identifiers
| code_info | Lot No. 2773813 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2014%22
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