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U.S. Department of Health and Human Services

Class 2 Device Recall SurFlo IV Catheter

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  Class 2 Device Recall SurFlo IV Catheter see related information
Date Initiated by Firm August 05, 2015
Create Date May 01, 2017
Recall Status1 Terminated 3 on May 01, 2017
Recall Number Z-1896-2017
Recall Event ID 76948
510(K)Number K891087  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product SurFlo IV Catheter
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 
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact
410-392-7226
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 2,478,200
Distribution US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = TERUMO MEDICAL CORP.
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