Reported Mar 4, 2015 · Terminated
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use…
Navilyst Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Navilyst Medical, Inc · 10 Glens Falls Technical Park · Glens Falls, NY · 12801
Is this the product you have?
- NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588
- Product UsageNAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems
- Lot codes and dates
Lots 42462994271288427932343094824336779434649443652504377114438450543990884413662441962844373684447518446277944877734498391450494845353924578775460402946100904612650461369946239344641236464240146500624654891466165346661694672802468050346828224687557468965346971954706129470661747081564718975472286747294664737452474207947509344760422477160747746674785145479057947962764804741480887748113754811376
- Amount recalled
- 562 units
This recall covers 60 products
The agency filed one notice per product. You are reading one of them; the other 59 are below.
47 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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