AVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
AVID Medical is recalling Halyard IV Start Kits because they contain applicators potentially contaminated with Aspergillus penicillioides.
What this means for you
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this as a Class I recall, which meets the rubric criteria for a Critical severity score.
Plain-English summary
AVID Medical, Inc. is recalling Halyard IV Start Kits (Model Number KRIV26-02) because they contain BD ChloraPrep Clear 1 mL Applicators that may be contaminated with Aspergillus penicillioides. The recall involves 288 kits (6 cases) that were distributed nationwide in the United States.
The affected kits are identified by Lot Number 1658437 and have an expiration date of 1/31/2027. The FDA has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
Healthcare facilities and consumers should stop using these kits immediately and contact AVID Medical, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — IV Start Kits
- Hazard
Distribution
Distributed nationwide across the United States.
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