Recall Z-0030-2015— Navilyst Medical, Inc

Name: FDA recall Z-0030-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-25

Class II · Terminated

Class II FDA medical device recall by Navilyst Medical, Inc, initiated 2014-08-25, terminated 2017-03-10. It names 3 FDA 510(k) clearances: K131038, K121990, K042061. 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. Reason: 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..

Recalling firm: Navilyst Medical, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-08-25
Terminated: 2017-03-10
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

3 on FDA's record

K131038 — NMI PICC MAXIMAL BARRIER NURSING KITSNavilyst Medical, Inc.·cleared 2013-05-09
K121990 — PICC CONVENIENCE KITNavilyst Medical, Inc.·cleared 2012-08-03
K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGEBecton Dickinson·cleared 2004-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.