BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit — Class II medical device recall Z-0025-2015
Terminated recall by Navilyst Medical, Inc, reported 2014-10-15, distributed nationwide. NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated
| Recall number | Z-0025-2015 |
|---|---|
| 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 | 2014-08-25 |
| Classified | 2014-10-06 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | sterility, packaging |
| Lot numbers | 4767162 |
| Model numbers | 75-023 |
| Expiration dates | 2015-06-30 |
Product
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Reason for recall
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
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-0025-2015. 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.