FDA Medical Device Recalls (openFDA)
Navilyst Medical, Inc: NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, 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.
- Recall number
- Z-1158-2015
- Recalling firm
- Navilyst Medical, Inc
- Product
- NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, 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.
- Status
- Terminated
- Initiated
- 2015-01-09
- Posted
- 2015-02-26
- Terminated
- 2017-03-10
- 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.
- Root cause
- Packaging
- Action
- Navilyst Medical sent an Urgent Medical Device Recall Notification letter dated January 9, 2015 to US customers (end users) via Federal Express. On January 20, 2015, Recall Notification Packages were sent via Federal Express to 2 International consignees (distributors). the letter identified the affected product, problem and actions to be taken. Customers are instructed to: " Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Segregate this product in a secure location for return to Navilyst Medical. " Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. " Complete and return the Reply Verification Tracking Form.
- Quantity
- 454 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.
- Lot, serial or model codes
- Lots 4247589, 4269253, 4271313, 4310122, 4342473, 4344822, 4387486, 4388838, 4414801, 4419289, 4437439, 4447579, 4474969, 4491873, 4504923, 4534887, 4534888, 4572805, 4604160, 4612239, 4624081, 4640706, 4641690, 4649150, 4651400, 4655126, 4660971, 4662034, 4666092, 4672688, 4680286, 4682905, 4690303, 4697126, 4697804, 4705250, 4708240, 4712693, 4721403, 4731034, 4742373, 4799479, 4807935, 4810688, 4814038, 4814614.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28