Recall Z-1896-2017 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Terumo Medical Corporation
SurFlo IV Catheter
| Date | Aug 5, 2015 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891087 | TERUMO SURFLO(R) I.V. CATHETER Terumo Medical Corp., Jun 23, 1989 |