Transpac¿ IV Bifurcated Monitoring Kit 48" — Class II medical device recall Z-0416-2017

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-0416-2017`
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	130 units
Reason classes	packaging
Model numbers	`011-42592-05`

Product

Transpac¿ IV Bifurcated Monitoring Kit 48", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05 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-0416-2017. 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.