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Terminated

Encision ES4107 Disposable AEM Cord, Sterile.

FDA Recall Z-1132-04 · Posted 2004-07-22

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2004-07-09
Date Terminated2004-12-14
Product Quantity73 units

Reason for Recall

Firm found pinholes in packaging which would compromise sterility.

Firm Action

Affected customers were notified by fax or mail on 7/15/2004.

Root Cause

Other

Distribution Pattern

AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K913625ELECTROSCOPE MONITOR, EM-1Electroscope, Inc. · 1991-12-30

Official Source

View FDA Recall →

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

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