AVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
AVID Medical is recalling Halyard IV Start Kits because they contain applicators contaminated with Aspergillus penicillioides.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides"
Plain-English summary
AVID Medical, Inc. is recalling 288 units of Halyard IV START KIT NON-STERILE (REF: KRIV26-02). The recall is due to the presence of Aspergillus penicillioides contamination in the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators included in the kits.
The affected products were distributed nationwide in the state of Nebraska. The specific lot number is 1658437 and the UDI is 10809160460481.
Consumers and healthcare facilities should stop using these kits and contact AVID Medical, Inc. for instructions on how to return the product.
The recalled product
- Product
- Halyard IV START KIT NON-STERILE REF: KRIV26-02
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — IV Start Kits
- Affected units
- 288
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)
- Lot Number: 1658437 UDI: 10809160460481
Distribution
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