dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
FDA Recall Z-1489-06 · Posted 2006-09-09
Recalling FirmCobe Cardiovascular, Inc
Recall StatusTerminated
Product CodeCAC
Date Initiated2006-08-04
Date Terminated2011-12-28
Product Quantity8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
Reason for Recall
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Firm Action
Consignees were notified by telephone and e-mail on 08/04/2006.
Root Cause
Other
Distribution Pattern
Nationwide, including VA facilities in CA and OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.