FDA-Device2022-04-06Class II
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Hazard
Devices distributed lacked regulatory clearance.
Sold states
US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.
Affected count
498 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2022More Baxter Healthcare Corporation recalls
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- FDA-Device2026-07-08Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
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