Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 255 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 (infection risk due to potential sterility breach) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Navilyst Medical, Inc. is recalling 255 units of NAMIC Convenience Kits, specifically the LEFT HEART KIT (UPN H965601017731, REF/Catalog No. 60101773). These sterile, single-use devices are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. The affected lots were distributed nationwide in the United States, as well as in Canada and Guam.
The recall was initiated because the labeled expiration dating of the affected product is not fully supported by shelf life verification testing. This deficiency 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.
Healthcare providers and facilities should stop using the affected lots immediately and contact Navilyst Medical for further instructions on return or disposal. The specific lot numbers affected are: 4245438, 4307306, 4313219, 4419588, 4445584, 4447457, 4472967, 4475647, 4505373, 4524286, 4535874, 4573138, 4603929, 4612618, 4614394, 4640699, 4641404, 4645492, 4654171, 4655816, 4661649, 4694300, 4696849, 4697815, 4705292, 4706335, 4716368, 4721360, 4750594, 4753523, 4767694, 4767695, and 4822754.
The recalled product
- Product
- NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, 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
- 255
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 4245438
- 4307306
- 4313219
- 4419588
- 4445584
- 4447457
- 4472967
- 4475647
- 4505373
- 4524286
- 4535874
- 4573138
- 4603929
- 4612618
- 4614394
- 4640699
- 4641404
- 4645492
- 4654171
- 4655816
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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- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
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