Company: Sechrist Industries, Inc.
Date of Enforcement Report: 6/30/04
Class: II

PRODUCT
Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. Recall # Z-1032-04.

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

CODE
Ventilators with production serial numbers beginning with a “00” prefix.

RECALLING FIRM/MANUFACTURER
Sechrist Industries, Inc., Anaheim, CA, by letter on May 20, 2004. 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. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
240 ventilators or manometers.

DISTRIBUTION
Nationwide and Internationally.