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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94713

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 30, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.

Z-2321-2024
Recall number
Z-2321-2024
Initiated
May 30, 2024
Classification
Class I
Status
Ongoing
Quantity
58,220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Nationwide distribution. International distribution to Canada, France, and Germany.

device · product 2 of 2

Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

Z-2322-2024
Recall number
Z-2322-2024
Initiated
May 30, 2024
Classification
Class I
Status
Ongoing
Quantity
350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: M07937; Lot numbers: 4210495, 4325617.

Distribution pattern

Nationwide distribution. International distribution to Canada, France, and Germany.