Z-1687-2023Class II

SMMT ambIT Reusable Program - Luer Cass

Name: Z-1687-2023 SMMT ambIT Reusable Program - Luer Cass
Creator: Avanos Medical, Inc.
Published: 2023-04-24
License: https://open.fda.gov/license/

Halyard Health / initiated 2023-04-24 / Terminated

FDA source

Avanos Medical, Inc. began a recall of SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 on 2023-04-24. FDA classified it as Class II and gives the reason as "Some of the ambIT kits were potentially distributed without an air in-line filter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1687-2023
Classification: Class II
Status: Terminated
Initiated: 2023-04-24
Posted: 2023-06-06
Terminated: 2024-08-02
Recalling firm: Halyard Health
Product: SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
Product code: FRN Pump, Infusion
Reason for recall: Some of the ambIT kits were potentially distributed without an air in-line filter.
FDA root cause: Under Investigation by firm
Action: Avanos Medical notified customers on 04/24/2023 via email. Customers were instructed to evaluate their inventory of products to determine if any of the impacted product codes were present in their facility. The letter provided information identifying the affected product. It was indicated to segregate and contact Avanos to coordinate return/destruction of impacted product. Additionally, customers were instructed to complete and return the Acknowledgement Form.
Quantity in commerce: 40 cases (200 cassettes)
Distribution: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Product codes and lots: Lot Number (Expiration Date): 30191805 (17 Jan 2025)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1687-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1684-2023	Class II	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-06
Z-1685-2023	Class II	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-06
Z-1686-2023	Class II	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-06
Z-1687-2023	Class II	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-06
Z-1688-2023	Class II	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-06

Product code FRN

K162165Class IIambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc. / cleared 2017-08-29

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)