CLASS II Device recall · Reported 4 Mar 2015 · FDA Enforcement Report
Namic Convenience Kit, Left Heart Kit, Upn H749601605351 recalled
Navilyst Medical is recalling Namic Convenience Kit, Left Heart Kit, Upn H749601605351, distributed nationwide in the US. The recall was initiated on 9 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1178-2015
- FDA event ID
- 70322
- Recalling firm
- Navilyst Medical, Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2015
- FDA classified
- 25 Feb 2015
- Reported
- 4 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 9 Jan 2015 | Recall initiated by company | |
| 25 Feb 2015 | Classified by FDA | +47 days |
| 4 Mar 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, 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.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 4608719
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
59 other products · FDA event 70322This product is part of a recall event; the main page for the event is Namic Convenience Kit, 3 Valve Kit, Upn H749600709971 recalled.
More recalls from Navilyst Medical
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Namic Convenience Kit, Radiology Kit, Upn H749601014911 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Kit, Upn H749601113111 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Cath Kit, Upn H7496010018151 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, Left Heart Kit, Upn H9656002072121 recalled | Navilyst Medical | Sterility | Nationwide |
| Device | CLASS II | Namic Convenience Kit, UPN H965601206511 recalled by Navilyst Medical | Navilyst Medical | Sterility | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |