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U.S. Department of Health and Human Services

Class 2 Device Recall Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

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  Class 2 Device Recall Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters see related information
Date Initiated by Firm September 24, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on August 11, 2015
Recall Number Z-0059-2015
Recall Event ID 69337
510(K)Number K110076  
Product Classification Reprocessed intravascular ultrasound catheter - Product Code OWQ
Product Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Code Information Lot Numbers: 1717945, 1721574, 1721575 and 1723123  Catalog Nos: M-5723-115, Model Number BIO10438577
Recalling Firm/
Manufacturer		 STERILMED, INC.
11400 73rd Ave N
Maple Grove MN 55369-5561
For Additional Information Contact Biosense Webster sales representative
763-488-3400
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.
Quantity in Commerce 22
Distribution US Distribution including the states of WA and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWQ and Original Applicant = STERILMED, INC.
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