AVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
AVID Medical is recalling 98 Halyard IV Start Kits because wrinkles in the paper lidding may breach the seal, compromising sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall involves a medical device with a defect that compromises sterility assurance, creating a risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
AVID Medical, Inc. is recalling 98 units of the Halyard IV Start Kit Non-Sterile (REF: KRIV26-02). The recall is limited to Lot Number 1658438, which has an expiration date of 7/31/2026 and UDI 10809160460481. These kits were distributed nationwide in the state of Nebraska.
The recall was initiated because the kits contain BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators that lack sterility assurance. This defect is caused by wrinkles in the paper lidding, which may breach the seal area. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected kits and contact AVID Medical, Inc. for further instructions or a replacement.
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
- 98
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:1658438 7/31/2026 UDI: 10809160460481
Distribution
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