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Terminated

Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.

FDA Recall Z-1490-06 · 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.

K982650AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)Dideco S.P.A. · 1998-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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