FDA (Devices) recall action 70322

Navilyst Medical, Inc recalled 60 products on 2015-03-04

The FDA (Devices) publishes a recall like this one as 60 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 60 pages.

Products: 60
Announced: 2015-03-04
Critical: 0
Units: 16,508

Why these products were recalled

The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–60 of 60

HighFDA (Devices)··2015-03-04
Navilyst NAMIC Convenience Kit Recall Due to Sterility Risk
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.
Product
NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, 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
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HighFDA (Devices)··2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 105 NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased risk of infection.
Product
NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, 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 Mo
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HighFDA (Devices)··2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 562 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased risk of infection.
Product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, 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 Monitor
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HighFDA (Devices)··2015-03-04
Navilyst NAMIC Convenience Kits Recalled for Sterility Verification Issues
Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, which may result in a sterility breach and increased infection risk.
Product
NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, 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.
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HighFDA (Devices)··2015-03-04
Navilyst NAMIC Convenience Kits Recalled for Sterility Concerns
Navilyst Medical is recalling 411 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.
Product
NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, 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.
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HighFDA (Devices)··2015-03-04
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.
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.
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HighFDA (Devices)··2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 2 units of NAMIC Convenience Kits because expiration dating is not fully supported by shelf life testing, posing a risk of sterility breach and infection.
Product
NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, 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.
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HighFDA (Devices)··2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling 180 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a risk of sterility breach and infection.
Product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, 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.
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HighFDA (Devices)··2015-03-04
Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
Navilyst Medical is recalling specific lots of NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.
Product
NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, 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.
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HighFDA (Devices)··2015-03-04
Navilyst NAMIC Convenience Kit Recall Due to Sterility Concerns
Navilyst Medical is recalling 5 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.
Product
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311, 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 Monitor
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