Medical device recalls Moderate risk

Centurion Medical Products product recalled over laceration hazard

Recall date
December 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Centurion Medical Products Corporation recalls Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING T…
Recall number
Z-1087-2020
FDA classification
Class II
Brand / firm
Centurion Medical Products Corporation
Sold / distributed
Nationwide Foreign: GHANA

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101358 LACERATION TRAY M101413 ADULT LUMBAR PUMP W NDLS MANO M101472A PREP PACK

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