NAMIC Convenience Kit — Class II medical device recall Z-1178-2015
Terminated recall by Navilyst Medical, Inc, reported 2015-03-04, distributed nationwide. The labelled expiration dating of the affected product is not fully supported by shelf life verification testi
| Recall number | Z-1178-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Navilyst Medical, Inc, Glens Falls, NY, United States |
| Recall initiated | 2015-01-09 |
| Classified | 2015-02-25 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2 units |
| Reason classes | sterility |
| Lot numbers | 4608719 |
| Model numbers | 60160535 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1178-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.