Z-2617-2021Class II

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or...

Name: Z-2617-2021 Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2017-10-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-10-17 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous... on 2017-10-17. FDA classified it as Class II and gives the reason as "Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec)". 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-2617-2021
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2021-09-30
Terminated: 2022-06-14
Recalling firm: Boston Scientific Corporation
Product: Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-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, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Product code: N/A
Reason for recall: Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Angiodynamics issued Recall Notifications Packages via Federal Express to 1 International Medical Facility on 2017-10-17. Letter states reason for recall, health risk and action to take: 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. Complete and return the Reply Verification Tracking Form. " If affected product is located in your institution, please can 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. o Email Reply Verification Tracking Form (preferred): [email protected] o Fax Reply Verification Tracking Form: Ann: PICC Kit Product Description Recall Coordinator Fax number 1 800-782-1357.
Quantity in commerce: 4 boxes (5/each)= 20 eaches
Distribution: Canada
Product codes and lots: Lot Number: 5210162 (UDI): H96560M7019951

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2617-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2617-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-30

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

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