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Navilyst Medical, Inc recalls PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Pro
Recalled October 15, 2014 · FDA recall Z-0030-2015 · Navilyst Medical
Hazard
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. · FDA Class II
Units
3 units/pouches
Sold at
Nationwide Distribution
Description
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.
Product
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
Manufacturer(s)
Navilyst Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →