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Terminated

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

FDA Recall Z-0544-04 · Posted 2004-02-24

Recalling FirmDeRoyal Surgical Tray
Recall StatusTerminated
Product CodeNAC
Date Initiated2004-01-19
Date Terminated2004-10-13
Product Quantity2,495 units

Reason for Recall

Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.

Firm Action

The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.

Root Cause

Other

Distribution Pattern

Nationwide and Europe

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945000MULTIDEX HYDROPHILIC WOUND DRESSINGLange Medical Products, Inc. · 1994-11-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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