ConvaTec 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
ConvaTec
Lot Codes / Batch Numbers
Product Order # 44650, Lot number 0902102.
Products Sold
Product Order # 44650, Lot number 0902102.
ConvaTec is recalling ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) due to Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026