Home / Recalls / Terumo Medical Corporation / Z-1376-2019

Z-1376-2019 Class I Terminated

Recalled by Terumo Medical Corporation — Elkton, MD

Recall Details

Product Type
Devices
Report Date
June 5, 2019
Initiation Date
April 26, 2019
Termination Date
September 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1481

Product Description

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Reason for Recall

There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Distribution Pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

Code Information

Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17

Other recalls by Terumo Medical Corporation

  • Z-1374-2019 Class I — SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI (April 26, 2019)
  • Z-1375-2019 Class I — SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-20 (April 26, 2019)
  • Z-2002-2019 Class II — Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 (February 8, 2019)
  • Z-2004-2019 Class II — Terumo Needle, 18G x 1", Product Code NN1825R (February 8, 2019)
  • Z-1998-2019 Class II — Terumo Sur-vet Needle, 20G x 1", Product Code 100204 (February 8, 2019)
  • Z-2006-2019 Class II — Terumo Needle, 30G x 1/2", Product Code NN3013R (February 8, 2019)
  • Z-1999-2019 Class II — Terumo Sur-vet Needle, 22G x 1", Product Code 100211 (February 8, 2019)
  • Z-2001-2019 Class II — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 (February 8, 2019)
  • Z-2003-2019 Class II — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 (February 8, 2019)
  • Z-2005-2019 Class II — Terumo Needle, 23G x 1", Product Code NN2325R (February 8, 2019)