Z-1896-2017Class II

SurFlo IV Catheter

Name: Z-1896-2017 SurFlo IV Catheter
Creator: Terumo Medical Corporation
Published: 2015-08-05
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2015-08-05 / Terminated / root cause: manufacturing process

FDA source

Terumo Medical Corporation began a recall of SurFlo IV Catheter on 2015-08-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1896-2017
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Posted: 2017-05-01
Terminated: 2017-05-01
Recalling firm: Terumo Medical Corp.
Product: SurFlo IV Catheter
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1896-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1896-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-01

Product code FOZ

K891087Class IITerumo Surflo(r) i.v. CatheterTerumo Medical Corp. / cleared 1989-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)