Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units; Boehringer Wound Systems, LLC, Norristown, PA 19404 Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.
FDA Recall Z-2045-2009 · Posted 2009-09-09
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Recalling FirmConvaTec
Recall StatusTerminated
Product CodeOMP
Date Initiated2009-07-29
Date Terminated2009-10-02
Product Quantity152 units
Reason for Recall
Labeling: The expiration date does not appear on the product label.
Firm Action
Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.
Root Cause
Labeling design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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