Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA, HC, NA A M
See all recalls from Baxter Healthcare Corporation →Recalled Product
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Hazard / Issue
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Brand Name: VOLARA System →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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