Home / Recalls / Terumo Medical Corporation / Z-1375-2019

Z-1375-2019 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
1431

Product Description

SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

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:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09

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-1376-2019 Class I — Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO- (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-2005-2019 Class II — Terumo Needle, 23G x 1", Product Code NN2325R (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-2006-2019 Class II — Terumo Needle, 30G x 1/2", Product Code NN3013R (February 8, 2019)