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U.S. Department of Health and Human Services

Class 2 Device Recall CENTURION MEDICAL PRODUCTS

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  Class 2 Device Recall CENTURION MEDICAL PRODUCTS see related information
Date Initiated by Firm December 23, 2022
Date Posted January 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1015-2023
Recall Event ID 91420
Product Classification Dressing change tray - Product Code OXQ
Product CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Code Information UDI/DI 10653160274841, Lot Numbers 22ABO498
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 The kit contained an expired component.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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