Recall Z-1995-2021— CAREFUSION
Class II · Terminated
Class II FDA medical device recall by CAREFUSION, initiated 2021-06-09, terminated 2024-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage..
- Recalling firm
- CAREFUSION
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-09
- Terminated
- 2024-07-08
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.