FDA-Device2021-07-07Class II
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
CAREFUSION
Hazard
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Sold states
U.S.: TN O.U.S.: None
Affected count
100 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2021Don't want to check this manually?
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