Recall Z-1444-2013 ยท BSO Catheter, Conduction, Anesthetic
I-Flow LLC
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
| Date | Jun 3, 2013 (initiated Jun 1, 2012) |
| Status | Terminated |
| Reason | I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned. |
| Root cause | Use error |
| Action | IFlow sent the customer notification letter on May 29, 2013, to 28 customers via FedEx along with a copy of the Service Guide to inform customers of the issue that can cause the Sting Ray to disconnect from the Catheter and how to prevent this problem from occuring. Customers are informed that in certain circumstances, ultrasound gel on the catheters significantly reduces the amount of force required to pull the catheter out of the Stingray connector. The In Service Guide clarifies that the method of catheter securement. It also instructs that wiping off any excess ultrasound gel from the c |
| Quantity | 450 units |
| Distribution | Nationwide distribution: USA including states of: CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904440 | LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS Preferred Medical Products, Jun 7, 1991 |