Recall Z-0032-2015— Navilyst Medical, Inc
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 Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, 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: 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 KITS
- K121990 — PICC CONVENIENCE KIT
- K042061 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
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 Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.