Z-0544-04

Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1...

Name: Z-0544-04 Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1...
Creator: DeRoyal Surgical Tray
Published: 2004-01-19
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2004-01-19 / Terminated / root cause: sterility

FDA source

DeRoyal Surgical Tray began a recall of 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... on 2004-01-19. The reason FDA records is "Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0544-04
Status: Terminated
Initiated: 2004-01-19
Posted: 2004-02-24
Terminated: 2004-10-13
Recalling firm: DeRoyal Industries, Inc.
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
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
Root cause tag: sterility
FDA 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 in commerce: 2,495 units
Distribution: Nationwide and Europe
Product codes and lots: Affected Lot Numbers: 66430, 68064, 89375, 93956, 103552, 110015, 106770, 346423, 354811, 387794, 492877, 492906

Product code NAC

K945000Class IMultidex Hydrophilic Wound DressingLange Medical Products, Inc. / cleared 1994-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)