Z-0710-2017Class II

BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog...

Name: Z-0710-2017 BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2016-08-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-08-29 / Terminated / root cause: packaging

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve... on 2016-08-29. FDA classified it as Class II and gives the reason as "Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0710-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-12-05
Terminated: 2018-06-15
Recalling firm: Boston Scientific Corporation
Product: BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs 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
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Navilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an incorrect expiration date. Actions to be taken: - Customers should immediately remove the affected product from inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to Navilyst Medical. - Immediately forward a copy of this recall notification to all sites to which customers may have further distributed affected product. Customers should also promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) via email to [email protected]. Customers with questions can call 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time). For questions regarding this recall 518-792-4112.
Quantity in commerce: 200 packages (boxes of 5)
Distribution: Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.
Product codes and lots: Batch/Lot: 5018263, 5020646, 5046472, 5051539

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0710-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-05
Z-0709-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-05
Z-0710-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-05

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)