Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy
FDA Recall Z-2609-2010 · Posted 2010-09-28
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Recalling FirmConvatec Inc.
Recall StatusTerminated
Product CodeOMP
Date Initiated2010-07-09
Date Terminated2011-06-07
Product Quantity1190 units
Reason for Recall
Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.
Firm Action
Recall notification letters were sent to 46 customers, acute care facilities and durable medical device distributors on July 9, 2010, by Federal Express.
Root Cause
Device 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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