Z-0035-2015Class II

PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product...

Name: Z-0035-2015 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product...
Creator: Navilyst Medical, Inc
Published: 2014-08-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-08-25 / Terminated / root cause: manufacturing process

FDA source

Navilyst Medical, Inc began a recall of PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705... on 2014-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0035-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-25
Posted: 2014-10-07
Terminated: 2017-03-10
Recalling firm: Boston Scientific Corporation
Product: PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, 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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 54 units/pouches
Distribution: Nationwide Distribution
Product codes and lots: Batch/Lot No. 4753215 (exp. 30-Apr-15)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0035-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0025-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0026-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0027-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0028-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0029-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0030-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0031-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0032-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0033-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0034-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0035-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06
Z-0036-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06

Product code LJS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)