RecallDepth

Encision ES4107 Disposable AEM Cord, Sterile.

This recall has been terminated (originally issued July 22, 2004).

Company
Encision, Inc.
Recall Initiated
July 9, 2004
Posted
July 22, 2004
Terminated
December 14, 2004
Recall Number
Z-1132-04
Quantity
73 units
Firm Location
Boulder, CO
Official Source
View on FDA website ↗

Reason for Recall

Firm found pinholes in packaging which would compromise sterility.

Distribution

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.

Lot / Code Info

REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.

Root Cause

Other

Action Taken

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

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