Z-0596-2019Class II

BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no...

Name: Z-0596-2019 BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2018-10-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-10-16 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481 on 2018-10-16. FDA classified it as Class II and gives the reason as "specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing...". 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-0596-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Posted: 2018-12-11
Terminated: 2020-06-26
Recalling firm: Boston Scientific Corporation
Product: BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 16, 2018, the firm issued Urgent Voluntary Medical Device Recall letters to affected customers. The letter identified the product issue. Customers were asked to do take the following immediate actions: 1. Actions to be taken IMMEDIATELY: - Stop using the product subject to recall. - Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have distributed affected product. - No actions are required on product that has been used or is presently in-use; the affected product is within its validated expiry 2. Complete and return the Reply Verification Tracking Form. - For any affected product to be returned, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. - Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. - Email Reply Verification Tracking Form (preferred): [email protected] - Fax Reply Verification Tracking Form: Attn: Xcela and BioFlo Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. - Please use our FedEx Account Number (284750594) to return this package via second day delivery. - Seal the box and return to: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 Attn: Xcela and BioFlo Re
Quantity in commerce: Box of 4 units
Distribution: Distributed to accounts in Florida. Foreign distribution to Great Britain.
Product codes and lots: 5231609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0596-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0595-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-11
Z-0596-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-11

Product code LJS

K121990Class IIPicc Convenience KitNavilyst Medical, Inc. / cleared 2012-08-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)