Class 2 Device Recall Pericardial Sump

• Date Initiated by Firm: January 24, 2008
• Date Posted: June 11, 2008
• Recall Status: Terminated on March 05, 2013
• Recall Number: Z-1176-2008
• Recall Event ID: 46745
• 510(K)Number: K982891
• Product Classification: suction pump - Product Code DTS
• Product: CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
• Code Information: Catalog Number SU-20602, Lot Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232 S050233 S050329 S050335NS S050416NS S050538NS S050741 S050759NS S050766NS S050858 S050923NS S050943NS S051041 S051130 S051151 S051175 S051275NS S051318NS S051356NS S051402NS S051490 S051511 S051560NS S051582NS S051596NS S051677ES S051844NS S051881 S051906ES S051925 S052007NS S052142NS S052193NS S052295 S052338NS S060045 S060092NS S060202 S060285 S060401NS S060402NS S060454NS Lot No. S060492NS S060683NS S060965NS S061010NS S061226 S061434 S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS S062055NS S062132 S070135NS S070252NS S070324 S070482NS S070501NS S070633 S070820NS S070870NS S070882 S070998 S071002NS S071456NS S071457NS S071458 S071459NS S071460NS S071534 S071606 S071607 S071688 S071731NS S071766 S071989 S072100NS S072121NS, and S072133NS
• Recalling Firm/ Manufacturer: California Medical Laboratories Inc; 1570 Sunland Ln; Costa Mesa CA 92626-1515
• For Additional Information Contact: Michael Webb; 714-556-7365
• Manufacturer Reason for Recall: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
• FDA Determined Cause: Process control
• Action: CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.
• Quantity in Commerce: 31,124 units of all models
• Distribution: Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
• 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 = DTS and Original Applicant = CALIFORNIA MEDICAL LABORATORIES, INC.