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U.S. Department of Health and Human Services

Class 2 Device Recall COBE Autotransfusion set.

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  Class 2 Device Recall COBE Autotransfusion set. see related information
Date Initiated by Firm August 04, 2006
Date Posted September 09, 2006
Recall Status1 Terminated 3 on December 28, 2011
Recall Number Z-1490-06
Recall Event ID 36168
510(K)Number K982650  
Product Classification autotransfusion set - Product Code CAC
Product Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.
Code Information COBE Product Code-AS4C12, Lot numbers: 0611600045, 0615000020, 0616400010, 0617800124, 0618600111, 0619200113, 0620600004-COBE Product Code- AS4C22, Lot Numbers: 0611600044, 0615000019, 0616400009, 0619200112, 0620600003, 0621300089-COBE Product Code- ASCBC12C, Lot Numbers: 0615700004, 0618600106, 0621300091-COBE Product Code-ASCBC22C, Lot Numbers: 0614300112, 0617100072, 0617800125, 0619200114, 0620600005- COBE Product Code-ASCBFC22C, Lot Numbers: 0611600046, 0613000074, 0613600144, 0615000021, 0615700003, 0617100073, 0617800126, 0619200115, 0619900050, 0620600006.
Recalling Firm/
Manufacturer		 Cobe Cardiovascular, Inc
14401 W 65th Way
Arvada CO 80004-3524
For Additional Information Contact Jack Ellison
303-467-6306
Manufacturer Reason
for Recall		 Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
FDA Determined
Cause 2		 Other
Action Consignees were notified by telephone and e-mail on 08/04/2006.
Quantity in Commerce 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
Distribution Nationwide, including VA facilities in CA and OH
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 = CAC and Original Applicant = DIDECO S.P.A.
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