FDA Medical Device Recalls (openFDA)
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 number
- Z-1814-2009
- Recalling firm
- ConvaTec
- 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.
- Status
- Terminated
- Initiated
- 2009-07-13
- Posted
- 2009-09-29
- Terminated
- 2009-10-02
- Reason
- Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
- Root cause
- Labeling Change Control
- 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.
- Quantity
- 764
- Distribution
- Nationwide distribution and ConvaTec sales rep in the UK and France.
- Lot, serial or model codes
- Product Order # 44650, Lot number 0902102.
- 510(k) numbers
- ["K061788"]
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 3011987967
- Firm city
- Skillman
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28