Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0106-2023Class II

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-09-07 / Terminated / root cause: sterility

MEDLINE INDUSTRIES, LP - Northfield began a recall of CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-0106-2023
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Product code
LRO General Surgery Tray
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.
Root cause tag
sterility
FDA root cause
Under Investigation by firm
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."
Quantity in commerce
18 kits
Distribution
US Nationwide distribution in the states of CA and TX.
Product codes and lots
UDI/DI 20653160222979, Lot Code 2022050690

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0106-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0106-2023Class IITerminatedVoluntary: Firm initiated