Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach
Navilyst Medical is recalling 161 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 involves a risk-of-harm product (sterile medical device) where a sterility breach could lead to infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Navilyst Medical, Inc. is recalling 161 units of NAMIC Convenience Kits (REF/Catalog No. 600521613). These sterile, single-use devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The recall is due to the fact that the labeled expiration dating of the affected product is not fully supported by shelf life verification testing.
This lack of testing support may result in a sterility breach. The use of a Fluid Management Convenience Kit where sterility has been breached may result in an increased risk of infection. The affected lots were distributed worldwide, including the US nationwide, Canada, and Guam.
Healthcare providers and facilities should stop using the affected lots immediately and contact Navilyst Medical for instructions on return or disposal. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
- Manufacturer
- Navilyst Medical, Inc
- Affected units
- 161
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 (20)
- Lots 4239391
- 4243486
- 4248969
- 4253169
- 4260193
- 4268148
- 4279179
- 4288388
- 4298216
- 4306873
- 4315493
- 4322272
- 4330719
- 4338372
- 4342371
- 4346174
- 4355672
- 4362474
- 4372470
- 4384182
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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