Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 3 units of 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 (infection risk from sterility breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Navilyst Medical, Inc. is recalling 3 units of NAMIC Convenience Kits, LEFT HEART, REF/Catalog No. PK0604436S. The recall is due to the labelled expiration dating of the affected product not being fully supported by shelf life verification testing. This issue may result in a sterility breach.
The affected product is a sterile, single-use device intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The specific lot number is 4683419. The product was distributed nationwide in the US, as well as in 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.
The recalled product
- Product
- NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, 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 Pr
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 3
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 4683419
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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