Navilyst Medical, Inc Recall: PICC Convenience Kit with Accessories, BioFlo PICC with ENDE
Navilyst Medical, Inc Recall: PICC Convenience Kit with Accessories, BioFlo PICC with ENDE is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Navilyst Medical, Inc; Product: PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96
| Recalling firm | Navilyst Medical, Inc |
|---|---|
| Product | PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution |
| Recall initiated | 20140825 |
| Recall number | Z-0035-2015 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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