SurFlo IV Catheter
This recall has been terminated (originally issued August 5, 2015).
- Company
- Terumo Medical Corporation
- Recall Initiated
- August 5, 2015
- Terminated
- May 1, 2017
- Recall Number
- Z-1896-2017
- Quantity
- 2,478,200
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
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
US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
Lot / Code Info
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
Root Cause
Process control
Action Taken
Terumo sent an Urgent Product Bulletin letter dated August 3, 2015. The letter identified the product the problem and the action needed to be taken by the customer. 1. CUSTOMERS MUST IMMEDIATELY DISCONTINUE USE, AND QUARANTINE ANY AVAILABLE STOCK, OF THE LISTED PRODUCT CODES. 2. DISTRIBUTORS MUST NOT DISTRIBUTE ANY OF THE LISTED PRODUCT CODES, QUARANTINE ANY AVAILABLE STOCK AND SEND THIS RECALL BULLETIN IMMEDIATELY TO EACH CUSTOMER THAT RECEIVED THESE PRODUCTS TO INFORM THEM OF THIS ISSUE. Terumo is taking this action to assure the safety of our customers and their patients even though it may cause a significant inconvenience. If this creates a critical shortage, please contact us immediately so we may try to provide assistance in procuring replacement or alternative product. For further questions, please call (410) 392-7226