Z-0195-2023Class II

Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock...

Name: Z-0195-2023 Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock...
Creator: Avanos Medical, Inc.
Published: 2022-09-14
License: https://open.fda.gov/license/

Halyard Health / initiated 2022-09-14 / Terminated / root cause: sterility

FDA source

Avanos Medical, Inc. began a recall of Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS... on 2022-09-14. FDA classified it as Class II and gives the reason as "Sterile extension sets were distributed without an expiration date". 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-0195-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-14
Posted: 2022-11-08
Terminated: 2023-08-31
Recalling firm: Halyard Health
Product: Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory
Product code: FPA Set, Administration, Intravascular
Reason for recall: Sterile extension sets were distributed without an expiration date
Root cause tag: sterility
FDA root cause: Incorrect or no expiration date
Action: AVANOS sent an URGENT: FIELD CORRECTION on 09/15/2022 via overnight FedEx to customers. The letter explained the issue and requested the following: "WHAT SHOULD I DO IN RESPONSE TO THIS FIELD CORRECTION? Our records show that you and/or your facility have received one or more of the impacted products. Avanos requests that you take the following actions: " CHECK all storage and usage locations to determine if any impacted product remains within your possession and QUARANTINE all impacted product identified. " COMPLETE and RETURN the attached Acknowledgement Form (Attachment 1) to Avanos. o Via email to [email protected] , subject line FCA-2022-007 Hospital Acknowledgement Form o Avanos Customer Service will contact you regarding product return Please respond within five (5) business days of receipt of this letter. If you have questions or require further assistance, please contact Avanos via email at [email protected]." The firm sent updated letters the week of October 10, 2022. The letters titled, "URGENT: PRODUCT RECALL" provided updated product descriptions.
Quantity in commerce: 1378 units
Distribution: US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Product codes and lots: ALL LOT CODES

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-16	2022-11-07

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)