Navilyst Medical Recalls NAMIC Left Heart Cath Kits Due to Sterility Concerns
Navilyst Medical is recalling 62 units of NAMIC Left Heart Cath Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach.
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 (infection risk due to potential sterility breach) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Navilyst Medical, Inc. is recalling 62 units of NAMIC Convenience Kits, specifically the Left Heart Cath Kit (REF/Catalog No. 601001815). The affected lots are 4361877, 4362670, 4384555, 4475742, 4534905, 4534906, 4572742, 4573424, 4603617, 4613738, 4623233, 4641655, 4642470, 4649930, 4654858, 4662098, 4666862, 4667793, 4672390, 4680972, 4681793, 4690126, 4696307, 4702956, 4706317, 4716358, 4726251, 4736913, 4747725, 4766391, 4778794, 4816062, 4820335, 4824146, and 4834213.
The recall was initiated because the labeled expiration dating of the affected product is not fully supported by shelf life verification testing. This lack of 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 products were distributed worldwide, including the United States, Canada, and Guam. These devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems and are for single use only. Healthcare providers and facilities should check their inventory for the specific lot numbers listed above and stop using any affected units.
The recalled product
- Product
- NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, 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…
- Manufacturer
- Navilyst Medical, Inc
- Category
- Medical Device — Catheter Kits
- Affected units
- 62
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 4361877
- 4362670
- 4384555
- 4475742
- 4534905
- 4534906
- 4572742
- 4573424
- 4603617
- 4613738
- 4623233
- 4641655
- 4642470
- 4649930
- 4654858
- 4662098
- 4666862
- 4667793
- 4672390
- 4680972
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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