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Recall Observatory FDA recall evidence

Device product

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

Z-0106-2023

September 07, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 90901
Status
Terminated
Classification
Class II
Quantity
18 kits
Official record key
device-enforcement:Z-0106-2023

Official wording

Reason: One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.

Code information: UDI/DI 20653160222979, Lot Code 2022050690

Distribution pattern: US Nationwide distribution in the states of CA and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.