Z-0504-2020Class II

BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022

Name: Z-0504-2020 BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2019-09-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-09-18 / Terminated

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022 on 2019-09-18. FDA classified it as Class II and gives the reason as "Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0504-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-18
Posted: 2019-11-21
Terminated: 2020-09-24
Recalling firm: Boston Scientific Corporation
Product: BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
FDA root cause: Under Investigation by firm
Action: On September 18, 2019, AngioDynamics sent Urgent Voluntary Medical Device Letters to impacted consignees. Customers were asked to do the following: IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. IN THE EVENT THAT THE PORT PRODUCT UNDER RECALL HAS BEEN UTILIZED (IMPLANTED) o The occurrence rate of an out of specification snap lock connector is less than 100%. o A port kit containing a properly sized snap lock connector allows the catheter to be securely attached to the port. o There are no actions required for an implanted port with a properly attached catheter. Customers were asked to complete and return the Reply Verification Form, and to package and return the recalled product.
Quantity in commerce: 582
Distribution: Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
Product codes and lots: 5478033, 5482424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0504-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0502-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0503-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0504-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21
Z-0505-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code LJT

K122767Class IINmi PortNavilyst Medical, Inc. / cleared 2013-04-30

MDM coverage of this record lists here, newest first.

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)