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U.S. Department of Health and Human Services

Class 2 Device Recall dideco Surgical blood wash set

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  Class 2 Device Recall dideco Surgical blood wash 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-1489-06
Recall Event ID 36168
510(K)Number K020647  
Product Classification Surgical blood wash set - Product Code CAC
Product dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
Code Information COBE Product Code WS55E, Lot numbers: 0603030047, 0604030059, 0605170017-COBE Product Code-WS125E, Lot Numbers: 0602170041, 0603030051, 0604210103-COBE Product Code WS175E, Lot Numbers: 0601180099, 0604030060-COBE Product Code-WS225E, Lot Numbers: 0601180100, 0602170042, 0603030049, 0603170058, 0604030061, 0604070035, 0604130050, 0605230075, 0607200059.
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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