Z-1329-2021Class II

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 -

Name: Z-1329-2021 AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 -
Creator: Oscor, Inc.
Published: 2021-03-10
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2021-03-10 / Terminated / root cause: sterility

FDA source

Oscor, Inc. began a recall of AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters on 2021-03-10. FDA classified it as Class II and gives the reason as "Potential for open seal on sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1329-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-10
Posted: 2021-04-01
Terminated: 2023-08-08
Recalling firm: Oscor Inc.
Product: AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Product code: DYB Introducer, Catheter
Reason for recall: Potential for open seal on sterile product
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.
Quantity in commerce: 500 devices
Distribution: US Nationwide distribution in the state of New York.
Product codes and lots: GUDID: 25051684026298; Lot Number DP-11759

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-04-01

Product code DYB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)