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Recall Observatory FDA recall evidence

Device product

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

Z-1087-2020

December 11, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84530
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1087-2020

Official wording

Reason: Incomplete seals on the sterile package may compromise the sterility

Code information: Product/Lot Code: M101156A DRESSING TRAY 2019041690 M101167A DRESSING TRAY 2018122190 M101168A DRESSING TRAY 2018122890 M101170A MAJOR DRESSING TRAY 2019040490 M101170A MAJOR DRESSING TRAY 2019021290 M101170A MAJOR DRESSING TRAY 2019020890 M101170A MAJOR DRESSING TRAY 2019012390 M101172B MINOR CORE DRESSING TRAY 2019041290 M101172B MINOR CORE DRESSING TRAY 2019030690 M101172B MINOR CORE DRESSING TRAY 2019020190 M101358 LACERATION TRAY 2019032290 M101358 LACERATION TRAY 2019021490 M101358 LACERATION TRAY 2019011890 M101413 ADULT LUMBAR PUMP W NDLS MANO 2019052190 M101472A PREP PACK 2019052990

Distribution pattern: Nationwide Foreign: GHANA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seals on the sterile package may compromise the sterility