Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1015-2023Class II

Centurion Medical Products, Silver Antimicrobial Vad Drive, Ref Dt18760

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-23 / Open, Classified

MEDLINE INDUSTRIES, LP - Northfield began a recall of CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760 on . FDA classified it as Class II and gives the reason as "The kit contained an expired component". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1015-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Centurion Medical Products, Silver Antimicrobial Vad Drive, Ref Dt18760
Product code
OXQ Dressing Change Tray
Reason for recall
The kit contained an expired component.
FDA root cause
Under Investigation by firm
Action
Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -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
1050 kits
Distribution
US Nationwide distribution in the states of NY, IN, FL, NJ, IL.
Product codes and lots
UDI/DI 10653160274841, Lot Numbers 22ABO498

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1015-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1015-2023Class IIOngoingVoluntary: Firm initiated