Medical Device Recall: Z-0036-2015

FDA Recalls dataset · Firm: Navilyst Medical, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2014-08-25 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2015.

Recall Res Number
Z-0036-2015
Recalling Firm / Manufacturer
Navilyst Medical, Inc
FEI Number
3017892510
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2014-08-25
Date Posted
2014-10-07
Date Terminated
2017-03-10
Product Code
LJS
Event Number
69085
Product Quantity
3 units/pouches
Product Description PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated 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 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.
Action Details BD Medical sent an Urgent Voluntary Medical Device Recall letter dated July 22, 2014, to all affected customers via Federal Express on August 25, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and quarantine all affected product. Immediately discontinue shipment of the affected product. Complete the Recall Response Card form and fax it back to BD at 1-201-847-6990. If the affected product was further distributed cusotmers should identify their cusotmers and notify them immediately of the product recall. Customers with questions were instructed to contact BD Customer Service at 1-888-237-2762, option 3. For questions regarding this recall call 518-742-4571.
Distribution Pattern Nationwide Distribution
Code Information / Serial Numbers Batch/Lot No. 4753765 (exp. 31-May-15)

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.