ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.
FDA Recall Z-1814-2009 · Posted 2009-09-29
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Recalling FirmConvaTec
Recall StatusTerminated
Product CodeOMP
Date Initiated2009-07-13
Date Terminated2009-10-02
Product Quantity764
Reason for Recall
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
Firm Action
Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide distribution and ConvaTec sales rep in the UK and France.
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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