Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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 risk of infection.
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: The recall involves a risk-of-harm product (sterility breach leading to infection) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Navilyst Medical, Inc. is recalling NAMIC Convenience Kits, 3V MANIFOLD KIT, REF/Catalog No. 60101162. The affected product is identified by Lot 4805300 and is intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems.
The recall is being conducted because the labelled expiration dating of the affected product is not fully supported by shelf life verification testing. This issue may result in a sterility breach. Use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection.
The product was distributed worldwide, including US Nationwide, Canada, and Guam. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, 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 4805300
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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