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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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 Class 2 Device Recall Centurionsee related information
Date Initiated by FirmMarch 01, 2024
Date PostedMay 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1917-2024
Recall Event ID 94448
Product Classification Tray, surgical - Product Code LRP
ProductCenturion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Code Information UDI/DI 40653160122945 (case), 10653160122944 (unit), Lot Numbers: 23JBX257, 23KMG455
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		Trumpet Needle Guide ring can detach when excessive pressure is applied.
FDA Determined
Cause 2		Process control
ActionMedline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.
Quantity in Commerce30 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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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