SurFlo IV Catheter
FDA Recall Z-1896-2017 · Posted None
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Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeFOZ
Date Initiated2015-08-05
Date Terminated2017-05-01
Product Quantity2,478,200
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.
Firm 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
Root Cause
Process control
Distribution Pattern
US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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