FDA Device recall Z-2161-2014
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring…
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring… by Icu Medical, citing ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2161-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Icu Medical |
| Distribution | OR |
Product
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
Reason
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Identifiers
| code_info | Lot No. 2866991 |
|---|
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-2161-2014%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.