Z-0490-2019Class II

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Name: Z-0490-2019 Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Creator: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Published: 2017-09-05
License: https://open.fda.gov/license/

Amsino Healthcare (USA) Inc. / initiated 2017-09-05 / Terminated / root cause: sterility

FDA source

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company began a recall of Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 on 2017-09-05. FDA classified it as Class II and gives the reason as "Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0490-2019
Classification: Class II
Status: Terminated
Initiated: 2017-09-05
Posted: 2018-11-20
Terminated: 2024-09-23
Recalling firm: Amsino Healthcare (USA) Inc.
Product: Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Product code: FQH Lavage, Jet
Reason for recall: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Root cause tag: sterility
FDA root cause: Other
Action: Firm sent recall notification letters to customers on 9/5/2017.
Quantity in commerce: 10,440
Distribution: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI
Product codes and lots: Model # FB-A-400-107 Lot Number: 4J006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0490-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0490-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-20

Product code FQH

K080779Class IIIrrisept Wound Cleansing SystemIrrimax Corporation / cleared 2009-02-04

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)