Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406.

FDA Recall Z-0239-2007 · Posted 2006-12-07

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTW
Date Initiated2006-09-14
Date Terminated2008-06-19
Product Quantity132

Reason for Recall

The hand crank handle may separate and detach from the unit during use.

Firm Action

Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.

Root Cause

Other

Distribution Pattern

Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915183SARNS 8000 MODULAR PERFUSION SYSTEM3M Health Care, Sarns · 1992-07-08

Official Source

View FDA Recall →

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

↑