TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV — Class II medical device recall Z-0506-2017
Terminated recall by ICU Medical, Inc., reported 2016-11-23, distributed nationwide. ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits co
| Recall number | Z-0506-2017 |
|---|---|
| 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 | 2016-09-27 |
| Classified | 2016-11-15 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 144 units |
| Reason classes | packaging |
| Model numbers | 46091-56 |
Product
TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
Reason for recall
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
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-0506-2017. 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.