—#208097

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.

FDA product code: NHJ — Device, Positive Pressure Breathing, Intermittent
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K192143, K200988
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Nationwide distribution. International distribution to Canada, France, and Germany.

Timeline

Recall initiated: 2024-05-30
Posted by FDA: 2024-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.