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Terminated

Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.

FDA Recall Z-1032-04 · Posted 2004-07-20

Recalling FirmSechrist Industries Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-05-20
Date Terminated2006-03-14
Product Quantity240

Reason for Recall

Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.

Firm Action

Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer.

Root Cause

Other

Distribution Pattern

Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920121SECHRIST IV-100B SAVI SYSTEMSechrist · 1993-02-01K833982MODEL IV 100B-DA INFANT VENTILATORSechrist Industries, Inc. · 1984-03-05K811141SECHRIST INFANT VENTRILATOR MODEL IV-100Sechrist Industries, Inc. · 1981-06-12

Official Source

View FDA Recall →

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

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