Home / Recalls / Oscor Inc. / Z-0646-2022

Z-0646-2022 Class II

Recalled by Oscor Inc. — Palm Harbor, FL

Recall Details

Product Type
Devices
Report Date
February 23, 2022
Initiation Date
December 22, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
549 units

Product Description

Destino Twist 14F (also branded as Guidestar 14F)

Reason for Recall

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Distribution Pattern

Distribution to TN and PA in USA OUS distribution to Czech Republic

Code Information

1) Model DST1405525 (Destino Twist 14F) - a) Lot: PQOC13475 [UDI: (01)00885672011123(11)211014(17)241001(10)PQOC13475] 2) Model D141103 (Guidestar 14F) - Lots: a) DP14073 - [UDI: (01)00885672010911(11)211114(17)241101(10)DP14073] b) DP14072 - [UDI: (01)00885672010911(11)211024(17)241001(10)DP14072] c) DP14071 - [UDI: (01)00885672010911(11)211023(17)241001(10)DP14701] d) DP13834 - [UDI: (01)00885672010911(11)210919(17)240901(10)DP13834] e) DP13828 - [UDI: (01)00885672010911(11)210914(17)240901(10)DP13828] f) DP13827 - [UDI: (01)00885672010911(11)210826(17)240801(10)DP13827] g) DP13811 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13811] h) DP13812 - [UDI: (01)00885672010911(11)210812(17)240801(10)DP13812] i) PQOC12995 - [UDI: (01)00885672010911(11)210709(17)240701(10)PQOC12995] j) PQOC12632 - [UDI: (01)00885672010911(11)210706(17)240701(10)PQOC12632] k) PQOC12633 - [UDI: (01)00885672010911(11)210705(17)240701(10)PQOC12633] l) PQOC12345 - [UDI: (01)00885672010911(11)210622(17)240601(10)PQOC12345] m) PQOC12330 - [UDI: (01)00885672010911(11)210602(17)240601(10)PQOC12330]

Other recalls by Oscor Inc.

  • 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-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-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)
  • Z-0790-2017 Class II — OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to (October 5, 2016)