Z-0714-2017Class II

Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing...

Name: Z-0714-2017 Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2016-06-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-06-08 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged... on 2016-06-08. FDA classified it as Class II and gives the reason as "There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0714-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-12-07
Terminated: 2018-06-15
Recalling firm: Boston Scientific Corporation
Product: Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are 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. Non-Valve lumens are indicated for central venous pressure monitoring
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for your returned product. Promptly complete, sign and return the Reply Verification Tracking Form by email to [email protected] or by Fax to 1-800-782-1357. For questions regarding this recall call 518-792-4112.
Quantity in commerce: 48 cartons (boxes of 5)
Distribution: Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
Product codes and lots: Lot #: 4941411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0714-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07
Z-0715-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07

Product code LJS

K142616Class IIPICC Maximal Barrier Nursing KitNavilyst Medical, Inc. / cleared 2014-10-14

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)