FDA Medical Device Recalls (openFDA)
ConvaTec: Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc contains 10 units; Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558 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.
- Recall number
- Z-2044-2009
- Recalling firm
- ConvaTec
- Product
- Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc contains 10 units; Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558 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.
- Status
- Terminated
- Initiated
- 2009-07-29
- Posted
- 2009-09-09
- Terminated
- 2009-10-02
- Reason
- Labeling: The expiration date does not appear on the product label.
- Root cause
- Labeling design
- 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.
- Quantity
- 128 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot number: 0808101, Exp 8/2010; lot number 0812102, exp. 12/2010.
- 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