Navilyst NAMIC Convenience Kit Recalled for Potential Sterility Breach
Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.
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 is classified as FDA Class II and involves a risk of infection due to potential sterility breach, which fits the criteria for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Navilyst Medical, Inc. is recalling NAMIC Convenience Kits (UPN H749601827221, REF/Catalog No. 60182722) due to concerns regarding the product's expiration dating. The labelled expiration dating of the affected product is not fully supported by shelf life verification testing. This deficiency may result in a sterility breach in the device.
The NAMIC Convenience Kits are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall affects Lot 4707501. The product was distributed worldwide, including the United States, Canada, and Guam.
Use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection. The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 1
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 4707501
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Navilyst Medical, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
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