Z-0661-2019Class II

Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces...

Name: Z-0661-2019 Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces...
Creator: ICU Medical, Inc.
Published: 2018-10-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-10-05 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090 on 2018-10-05. FDA classified it as Class II and gives the reason as "Potential for leakage due to defect in the thermoset check valve component". 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-0661-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-05
Posted: 2018-12-22
Terminated: 2021-03-25
Recalling firm: Abbott Medical
Product: Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Product code: KRB Probe, Thermodilution
Reason for recall: Potential for leakage due to defect in the thermoset check valve component.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On October 5, 2018, ICU Medical URGENT MEDCAL DEVICE RECALL letters were sent to ICU Medical's consignees advising them of this matter. Each letter contained a response form and a return label.
Quantity in commerce: 27,250 units total
Distribution: United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
Product codes and lots: Item number:41412-01. Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611). Expiration Date 01/01/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0661-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0661-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0662-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0663-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code KRB

K884318Class IIThermoset(tm) Closed Loop Delivery SystemAbbott Laboratories / cleared 1988-12-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)