Transpac IT w/10 cc Safeset Reservoir — Class II medical device recall Z-2165-2014
Terminated recall by ICU Medical, Inc., reported 2014-08-13, distributed in OR. ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack
| Recall number | Z-2165-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-08-07 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2014-09-25 |
| Distributed | OR |
| Countries outside the US | AU |
| Quantity | 50 units |
| Reason classes | packaging |
| Lot numbers | 2837897 |
| Model numbers | 011-46112-21 |
Product
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2165-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.