Carefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets due to leakage defects. The affected units failed validation testing for leakage and were inadvertently released to the Tennessee market.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device with no reported illnesses or injuries. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' which corresponds to severity score 3 (High). A leakage defect in a sterile medical infusion connector represents a direct risk of contamination or improper drug delivery.
Plain-English summary
Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets with 2 clear needleless connectors (Catalog Number MP9246-C, Lot Number 20087194). These devices are used for direct injection, intermittent infusion, continuous infusion, or aspiration in medical settings.
A portion of the validation lot was inadvertently released to the market without meeting the required validation testing criteria regarding leakage. The affected units do not meet quality standards for leakage performance.
Approximately 100 units were distributed in Tennessee. Consumers and healthcare providers in possession of this product should immediately cease use and contact their healthcare provider or Carefusion for further guidance on replacement or disposal.
The recalled product
- 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.
- Manufacturer
- CAREFUSION
- Hazard
- leakage
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194
Distribution
Distributed in 1 state:
- TN
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