Z-2321-2024Class I

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for...

Name: Z-2321-2024 Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for...
Creator: Baxter Healthcare Corporation
Published: 2024-05-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-05-30 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing... on 2024-05-30. FDA classified it as Class I and gives the reason as "Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2321-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-30
Posted: 2024-07-17
Recalling firm: Baxter Healthcare Corporation
Product: Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
Reason for recall: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter Healthcare notified customers on about 05/30/2024 via letter sent first-class mail. The letter instructed facilities to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, and complete and return the acknowledgement form. If the product was further distributed, they were instructed to notify customers if product was further distributed. The letter instructed patients to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, however if they do not have other options in stock, in order to not delay therapy, you may continue to use with caution. Visually inspect the nebulizer port prior to therapy and assess for ventilator gas flow leaks for the duration of therapy. They were also instructed to complete and return the acknowledgement form.
Quantity in commerce: 58,220 units
Distribution: Nationwide distribution. International distribution to Canada, France, and Germany.
Product codes and lots: Product Codes: M08473/M08474; Lot numbers: 2171WA, 2237WA, 2238WA, 2241WA, 2242WA, 2243WA, 2244WA, 2249WA, 2250WA, 2251WA, 2285WA, 2286WA, 2290WA, 2297WA, 2298WA, 2299WA, 2307WA, 2308WA, 2311WA, 2332WA, 2333WA, 2341WA, 2342WA, 2349WA, 2355WA, 2356WA, 2357WA, 2363WA, 2364WA, 3019WA, 3061WA, 3067WA, 3068WA, 3069WA, 3072WA, 3073WA, 3074WA, 3080WA, 3081WA, 3094WA, 3095WA, 3096WA, 3100WA, 3101WA, 3102WA, 3103WA, 3109WA, 3110WA, 3111WA, 3123WA, 3124WA, 3152WA, 3156WA, 3157WA, 3158WA, 3213WA, 3214WA, 3215WA, 3219WA, 3240WA, 3241WA, 3268WA, 3270WA, 3271WA, 3272WA, 3297WA, 3298WA, 3299WA, 3300WA, 3303WA, 3304WA, 3305WA, 3306WA, 3310WA, 3311WA, 3313WA, 3326WA, 3327WA, 3328WA, 3331WA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2321-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2321-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17
Z-2322-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code NHJ

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)