Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY ...
FDA Recall #Z-1087-2020 — Class II — December 11, 2019
Product Description
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
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Recalling Firm
Centurion Medical Products Corporation — Williamston, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
Nationwide Foreign: GHANA
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.