Z-2812-2016Class II

Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze...

Name: Z-2812-2016 Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze...
Creator: ICU Medical, Inc.
Published: 2016-08-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-08-10 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole... on 2016-08-10. FDA classified it as Class II and gives the reason as "ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers". 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-2812-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-10
Posted: 2016-09-15
Terminated: 2017-07-10
Recalling firm: Abbott Medical
Product: Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: 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.
Product code: DRS Transducer, Blood-Pressure, Extravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to [email protected].
Quantity in commerce: 760 units
Distribution: US Nationwide Distribution
Product codes and lots: 3279183 3226553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2812-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2805-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2806-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2807-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2808-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2809-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2810-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2811-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2812-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2813-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2814-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2815-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2816-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2817-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2818-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2819-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2820-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2821-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2822-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2823-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2824-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2825-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2826-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2827-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2828-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15

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)