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 infection risk.
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 (Catalog No. PK193168S, Lot 4589519) because the labeled expiration dating is not fully supported by shelf life verification testing. This deficiency may result in a sterility breach in the product.
The affected kits are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall covers units distributed worldwide, including the United States, Canada, and Guam. Use of a kit where sterility has been breached may result in an increased risk of infection.
Healthcare providers and facilities should stop using the affected lots and contact Navilyst Medical for instructions on return or disposal. Consumers should not use these products and should contact their healthcare provider if they have used the affected kits.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, 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 4589519
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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FDA (Devices) · 2015-03-04
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