ProductGuru
AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

[Recalled] CATH LAB KIT, Item No. 46096-25 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 e

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductCATH LAB KIT, Item No. 46096-25 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
Brand / manufacturerICU Medical, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0519-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 September 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from ICU Medical, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

Shop Recalled CATH LAB KIT
Search on Amazon ›Find on eBay ›
As an Amazon Associate and eBay Partner, we may earn from qualifying purchases.
Related articles

Explore by topic

Looking up a product? Use ProductGuru — free barcode & product database with 35M+ products. Search by EAN / UPC barcode.
Was this page helpful?