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- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PA…
Recall number
Z-1095-2020
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- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF

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