FDA Device recall Z-1204-2015
NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13…
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D13… by Navilyst Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1204-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-09 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Navilyst Medical |
| Distribution | US |
Product
NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, 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
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.
Identifiers
| code_info | Lots 4251421, 4261990, 4282367, 4292263, 4310927, 4332731, 4337139, 4355702, 4361719, 4374408, 4387108, 4406974, 442189…Lots 4251421, 4261990, 4282367, 4292263, 4310927, 4332731, 4337139, 4355702, 4361719, 4374408, 4387108, 4406974, 4421890, 4428330, 4440410, 4442751, 4472601, 4489987, 4502014, 4517118, 4549816, 4561987, 4576305, 4584997, 4596976, 4598870, 4614644, 4620378, 4622543, 4637814, 4640980, 4643981, 4651520, 4657147, 4657812, 4672188. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1204-2015%22
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