Z-2163-2014Class II

Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated...

Name: Z-2163-2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated...
Creator: ICU Medical, Inc.
Published: 2014-07-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-07-18 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze... on 2014-07-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2163-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Posted: 2014-08-07
Terminated: 2014-09-25
Recalling firm: Abbott Medical
Product: Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 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.
Product code: DRS Transducer, Blood-Pressure, Extravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.
Quantity in commerce: 100 units
Distribution: Worldwide Distribution - USA including Oregon and Internationally to Australia.
Product codes and lots: Lot No. 2866974

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2163-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2158-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2159-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2160-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2161-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2162-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2163-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2164-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07
Z-2165-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-07

Product code DRS

K061573Class IITranspac III Disposable Straight Pressure Transducer and KitHospira, Inc. / cleared 2006-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)