The Recall Desk
HighFDA (Devices)·Z-1154-2015·Announced 2015-03-04

Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

Navilyst Medical is recalling 438 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, which aligns with the 'High' severity criteria.

Plain-English summary

Navilyst Medical, Inc. is recalling 438 units of NAMIC Convenience Kits, 3 Valve Kit Cardiovascular Procedure Kits (Catalog No. 60040313). The affected lots are 4606270, 4612210, 4616194, 4617867, 4623170, 4641411, 4649602, 4653594, 4655245, 4661836, 4663939, 4665119, 4666347, 4671948, 4672567, 4680203, 4690158, 4690850, 4701000, 4704036, 4704366, 4712691, 4717116, 4719844, 4729019, 4729020, 4771553, 4780273, 4797512, 4805753, 4809347, 4821812, and 4831367. The products 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.

These kits are intended for use in Fluid Management and/or Invasive Pressure Monitoring Systems. 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, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, 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
Manufacturer
Navilyst Medical, Inc
Category
Medical Device — Cardiovascular Procedure Kit
Hazard
Affected units
438

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 4606270
  • 4612210
  • 4616194
  • 4617867
  • 4623170
  • 4641411
  • 4649602
  • 4653594
  • 4655245
  • 4661836
  • 4663939
  • 4665119
  • 4666347
  • 4671948
  • 4672567
  • 4680203
  • 4690158
  • 4690850
  • 4701000
  • 4704036

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

Same manufacturer · Navilyst Medical, Inc

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Same hazard · sterility breach

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