Home / Recalls / Oscor, Inc. / Z-1329-2021

Z-1329-2021 Class II Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

Recall Details

Product Type
Devices
Report Date
April 7, 2021
Initiation Date
March 10, 2021
Termination Date
August 8, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 devices

Product Description

AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

Reason for Recall

Potential for open seal on sterile product

Distribution Pattern

US Nationwide distribution in the state of New York.

Code Information

GUDID: 25051684026298; Lot Number DP-11759

Other recalls by Oscor, Inc.

  • Z-0646-2022 Class II — Destino Twist 14F (also branded as Guidestar 14F) (December 22, 2021)
  • Z-0391-2019 Class I — TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, (September 26, 2018)
  • Z-2340-2017 Class I — ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATA (March 31, 2017)
  • Z-2733-2017 Class I — ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, (March 31, 2017)
  • Z-0798-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is design (October 5, 2016)
  • Z-0805-2017 Class II — OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed t (October 5, 2016)
  • Z-0792-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to (October 5, 2016)
  • Z-0819-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog (October 5, 2016)
  • Z-0812-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catal (October 5, 2016)
  • Z-0799-2017 Class II — OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designe (October 5, 2016)