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Terminated

Vascular Drape, Surgical drape and drape accessories; Reference Number: EF 00-902776-01; Packaged in a box of 10.

FDA Recall Z-1372-2008 · Posted 2008-07-23

Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2007-12-20
Date Terminated2008-07-22
Product Quantity158 units

Reason for Recall

No Premarket Notification: Product does not have FDA 510(k) approval for use.

Firm Action

Consignees were notified by an Urgent Recall Notice letter on 12/20/2007. The letter instructed users to stop using and to dispose of the recalled drapes. For additional information, contact 1-800-874-7378.

Root Cause

PMA

Distribution Pattern

Nationwide Distribution including states of AL, CA, FL, MA, MD, MO, NJ, NY, PA, OR, SC and TX.

Official Source

View FDA Recall →

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

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