FDA recall Z-0106-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

Reason for recall

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.

Distribution

US Nationwide distribution in the states of CA and TX.

Key facts

Status
Terminated
Initiation date
2022-09-07
Report date
2022-10-26
Termination date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2023