FDA Recall Terminated

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

Recall: Z-0106-2023 · Initiated September 7, 2022

Recall

Recall Number
Z-0106-2023
Event Number
90901
Firm
MEDLINE INDUSTRIES, LP Northfield
FEI Number
1417592
Product Code
LRO
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
September 7, 2022
Posted
October 20, 2022
Terminated
March 4, 2026
Address
3 Lakes Dr, Northfield, IL, 60093-2753

Description

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

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.

Action

Medline Industries issued a Medical Device Recall note on 09/08/2022 by mail and email. The notice explained the problem and the potential hazard and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-131-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Distribution

US Nationwide distribution in the states of CA and TX.

Quantity

18 kits