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U.S. Department of Health and Human Services

Class 2 Device Recall PICC Convenience Kit with Accessories

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 Class 2 Device Recall PICC Convenience Kit with Accessoriessee related information
Date Initiated by FirmAugust 25, 2014
Date PostedOctober 07, 2014
Recall Status1 Terminated 3 on March 10, 2017
Recall NumberZ-0031-2015
Recall Event ID 69085
510(K)NumberK042061 K121990 K131038 
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
ProductPICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
Code Information Batch/Lot No. 4748898 (exp. 31-May-15)
Recalling Firm/
Manufacturer		 Navilyst Medical, Inc
10 Glens Falls Technical Park
Glens Falls NY 12801
For Additional Information ContactMr. Michael Duerr
518-742-4571
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBD 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.
Quantity in Commerce45 units/pouches
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJS
510(K)s with Product Code = LJS
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