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U.S. Department of Health and Human Services

Class 2 Device Recall Pericardial Sump

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  Class 2 Device Recall Pericardial Sump see related information
Date Initiated by Firm January 24, 2008
Date Posted June 11, 2008
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-1175-2008
Recall Event ID 46745
510(K)Number K982891  
Product Classification suction pump - Product Code DTS
Product CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626
Code Information Catalog Number SU-20601, Lot Number S03482 
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 2		 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.
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