Home / Recalls / Terumo Medical Corporation / Z-1896-2017

Z-1896-2017 Class II Terminated

Recalled by Terumo Medical Corporation — Elkton, MD

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
August 5, 2015
Termination Date
May 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,478,200

Product Description

SurFlo IV Catheter

Reason for Recall

According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.

Distribution Pattern

US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.

Code Information

PRODUCT CODE 3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2419CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA SR-TL2225M 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2225CA 3SR-OX2419CA SR-TL2419M 3SR-OX2419CA 3SR-OX2419CA 3SR-OX2419CA LOT NUMBER RF2727 RF2727 RG0227 RG0927 RG0927 RG1627 RG2027 RG2027 RG2327 RH0727 RH1427 RH1427 RH1427 RH2127 RH2827 RH3127 RK0427 RK0427 RK1127 RK1827 RK2527 RL0227 RL0227 RL0827 RL1527 RL2227

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)