Z-1976-2026Class I

Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01

Name: Z-1976-2026 Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01
Creator: AVID Medical, Inc.
Published: 2026-03-13
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-03-13 / Open, Classified

FDA source

AVID Medical, Inc. began a recall of Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01 on 2026-03-13. FDA classified it as Class I and gives the reason as "Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1976-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-13
Posted: 2026-05-01
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA root cause: Under Investigation by firm
Action: Owens and Minor/Avid Medical notified consignees on about 03/13/2026 and then sent an updated letter on about 03/18/2026 with additional kits added to the affected product list. The notice explained the issue was initiated by Medline Industries, risk associated with syringe disconnection and loose connection, and instructed consignees to identify, segregate and quarantine all affected product, and to apply warning labels to affected AVID kits to ensure all users are aware of the actions requested by Medline. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure. All usage guidelines and the Instructions for Use are provided in Medline s recall letter. Consignees were also instructed to complete and return the Recall Response Form as well as to notify customers if affected kits were further distributed to ensure all end-users are appropriately notified and maintain records of effectiveness.
Quantity in commerce: 204 kits
Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX.
Product codes and lots: Model Number: UINR44-01. UDI (Kit Lot Number): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1970-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1971-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1972-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1973-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1974-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1975-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1976-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1977-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1978-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-1979-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

Product code OEZ

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