Device 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.
Z-2321-2024
Product summary
- Event
- Event 94713
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 58,220 units
- Official record key
device-enforcement:Z-2321-2024
Official wording
Reason: 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.
Derived failure modes
-
Unknown
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.