Home / Recalls / Terumo Medical Corporation / Z-2738-2016

Z-2738-2016 Class II Terminated

Recalled by Terumo Medical Corporation — Elkton, MD

Recall Details

Product Type
Devices
Report Date
September 14, 2016
Initiation Date
March 16, 2016
Termination Date
January 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,370,995 eaches have been distributed to the field

Product Description

PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

Reason for Recall

Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.

Distribution Pattern

Nationwide Distribution

Code Information

Please see Attachment 3

Other recalls by Terumo Medical Corporation

  • Z-1375-2019 Class I — SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-20 (April 26, 2019)
  • 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-2001-2019 Class II — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 (February 8, 2019)
  • Z-2000-2019 Class II — Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 (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-2003-2019 Class II — Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 (February 8, 2019)
  • Z-1999-2019 Class II — Terumo Sur-vet Needle, 22G x 1", Product Code 100211 (February 8, 2019)