FDAFDA · Food and drugs·Recall number Z-1896-2017
SurFlo IV Catheter
Published May 10, 2017 · Recall initiated: August 5, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Medical Corporation
- Distributor
- US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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