Reported Jul 24, 2024 · Ongoing
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara.…
Baxter Healthcare Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
- Lot codes and dates
- Product CodesM08473/M08474
- Lot numbers
80 of 80 codes
2171WA2237WA2238WA2241WA2242WA2243WA2244WA2249WA2250WA2251WA2285WA2286WA2290WA2297WA2298WA2299WA2307WA2308WA2311WA2332WA2333WA2341WA2342WA2349WA2355WA2356WA2357WA2363WA2364WA3019WA3061WA3067WA3068WA3069WA3072WA3073WA3074WA3080WA3081WA3094WA3095WA3096WA3100WA3101WA3102WA3103WA3109WA3110WA3111WA3123WA3124WA3152WA3156WA3157WA3158WA3213WA3214WA3215WA3219WA3240WA
- Amount recalled
- 58,220 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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