FDA Medical Device Recalls (openFDA)
DeRoyal Surgical Tray: Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
- Recall number
- Z-0544-04
- Recalling firm
- DeRoyal Surgical Tray
- Product
- Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box
- Status
- Terminated
- Initiated
- 2004-01-19
- Posted
- 2004-02-24
- Terminated
- 2004-10-13
- Reason
- Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
- Root cause
- Other
- Action
- The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.
- Quantity
- 2,495 units
- Distribution
- Nationwide and Europe
- Lot, serial or model codes
- Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015, 106770, 346423, 354811, 387794, 492877, 492906
- 510(k) numbers
- ["K945000"]
- PMA numbers
- not on file
- Product code
- NAC
- Firm FEI
- 3003040625
- Firm city
- New Tazewell
- Firm state
- TN
- 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