|
Class 2 Device Recall dideco Surgical blood wash set |
|
Date Initiated by Firm |
August 04, 2006 |
Date Posted |
September 09, 2006 |
Recall Status1 |
Terminated 3 on December 28, 2011 |
Recall Number |
Z-1488-06 |
Recall Event ID |
36168 |
510(K)Number |
K982650
|
Product Classification |
Surgical blood wash set - Product Code CAC
|
Product |
dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc. |
Code Information |
COBE Product Code-WS55C, Lot numbers: 0604030062, 0605310137-COBE Product Code WS125C, Lot Numbers: 0602170043, 0603030050, 0603170057, 0603270019, 0604210104, 0605310135, 0606200074, 0606280029-COBE Product Code WS225C Lot Numbers: 0602100031, 0602170037, 0602240025, 0603030052, 0603100018, 0603270020, 0604070034, 0604130049, 0605030155, 0606200075, 0607200058. |
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.
|
|
|
|