| Class 2 Device Recall Sarns Flexible Weighted Sucker | |
Date Initiated by Firm | February 25, 2011 |
Date Posted | April 15, 2011 |
Recall Status1 |
Terminated 3 on December 10, 2012 |
Recall Number | Z-2011-2011 |
Recall Event ID |
58125 |
Product Classification |
Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
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Product | Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. Terumo Cardiovascular Systems, Ashland, MA .
The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. |
Code Information |
Lot numbers: MD22, MK09, MK23, and NA03. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | 734-741-6173 |
Manufacturer Reason for Recall | The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the products's instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting |
FDA Determined Cause 2 | Device Design |
Action | SEE UPDATE BELOW IN ALL CAPS.
The firm, Terumo Cardiovascular Systems (Terumo CVS), sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that the product's Indications For Use (IFU) are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However, this is not stated in the IFU. In addition, the customers were instructed to read and understand the changes and clarifications to the product's IFU; review the Medical Device Correction notice; assure that all users are aware of this notice, and confirm receipt of this communication by faxing the attached Customer Response Form via fax to: Terumo CVS Customer Service at 800-292-6551 (US only).
If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818. Customers Service hours: Monday-Friday, 8AM-6PM.
ON 8/30/2011 THE FIRM ISSUE A LETTER ENTITLED "URGENT MEDICAL DEVICE RECALL" THAT STATED "AFTER FURTHER CONSIDERATION, TERUMO CVS DECIDED TO DISCONTINUE SALES OF THE WEIGHTED FLEXIBLE SUCKER AND IS ASKING USERS TO RETURN ALL UNUSED PRODUCT" TO THE FIRM. |
Quantity in Commerce | 11,690 |
Distribution | Worldwide distribution: USA (Nationwide) and countries including: BRAZIL, BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, and MALAYSIA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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