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U.S. Department of Health and Human Services

Class 2 Device Recall CalMed SU12202

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 Class 2 Recall
CalMed SU12202
see related information
Date Posted January 07, 2013
Recall Status1 Terminated on March 04, 2013
Recall Number Z-0649-2013
Recall Event ID 63896
Premarket Notification
510(K) Number
K982891 
Product Classification Sucker, Cardiotomy Return, Cardiopulmonary Bypass - Product Code DTS
Product Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Code Information Catalog No: SU-12202 Lot No: S112462, S111480
Recalling Firm/
Manufacturer
California Medical Laboratories Inc
1570 Sunland Ln
Costa Mesa, California 92626-1515
For Additional Information Contact Jodi Taylor
714-556-7365 Ext. 201
Manufacturer Reason
for Recall
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.
Quantity in Commerce S112462=995 units & S111480 1430 units
Distribution Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTS and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.
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