Recall Z-0059-2015 · OWQ Reprocessed Intravascular Ultrasound Catheter
STERILMED, INC.
Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
| Date | Oct 9, 2014 (initiated Sep 24, 2014) |
| Status | Terminated |
| Reason | Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne |
| Root cause | Process control |
| Action | Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form i |
| Quantity | 22 |
| Distribution | US Distribution including the states of WA and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER Sterilmed, Inc., Aug 18, 2011 |