Z-1072-2019Class II

ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing...

Name: Z-1072-2019 ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing...
Creator: ICU Medical, Inc.
Published: 2018-11-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-11-27 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole... on 2018-11-27. FDA classified it as Class II and gives the reason as "Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances...". 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-1072-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-27
Posted: 2019-03-28
Terminated: 2022-02-01
Recalling firm: Abbott Medical
Product: ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Product code: DRS Transducer, Blood-Pressure, Extravascular
Reason for recall: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 11/27/18, Urgent Medical Device Recall notices were sent via traceable mailing to customers informing them to discontinue use and distribution of the affected product. In addition, customers were asked to quarantine and return affected product, and to complete and return response forms. Customers were instructed to inform all potential users of the product within their organization, and if the product had been further distributed, to immediately notify these additional customers. Customers with additional questions were encouraged to call: Global Complaint Management @ 1-844-654-7780 ([email protected]), Medical Information @ 1-800-241-4002 option 6 ([email protected]), or Customer Care @ 1-949-366-4208.
Distribution: U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
Product codes and lots: Lot/UDI: 3529857/ (01)0 0840619 04495 4 (17) 200901 (30) 01 (10) 3529857

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1072-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28
Z-1071-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28
Z-1072-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code DRS

K831506Class IIDisp. Transducer W/monitoring Kit TransSorensen Research / cleared 1983-08-12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)