Home / Recalls / Oscor, Inc. / Z-0800-2017

Z-0800-2017 Class II Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

Recall Details

Product Type
Devices
Report Date
December 28, 2016
Initiation Date
October 5, 2016
Termination Date
July 26, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

Product Description

OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

Reason for Recall

Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

Distribution Pattern

Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM

Code Information

Lot #'s: C1-09396 Exp. November 17, 2017, C1-09396 Exp. November 17, 2017, C1-08804 Exp. April 1, 2017, and C1-09396 Exp. November 17, 2017

Other recalls by Oscor, Inc.

  • Z-0646-2022 Class II — Destino Twist 14F (also branded as Guidestar 14F) (December 22, 2021)
  • Z-1329-2021 Class II — AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: inten (March 10, 2021)
  • Z-0391-2019 Class I — TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, (September 26, 2018)
  • Z-2733-2017 Class I — ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, (March 31, 2017)
  • Z-2340-2017 Class I — ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATA (March 31, 2017)
  • Z-0805-2017 Class II — OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed t (October 5, 2016)
  • Z-0798-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is design (October 5, 2016)
  • Z-0792-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to (October 5, 2016)
  • Z-0799-2017 Class II — OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designe (October 5, 2016)
  • Z-0812-2017 Class II — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catal (October 5, 2016)