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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE/ CENTURION MEDICAL PRODUCTS Surgical convenience kits

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 Class 2 Device Recall MEDLINE/ CENTURION MEDICAL PRODUCTS Surgical convenience kitssee related information
Date Initiated by FirmDecember 07, 2022
Date PostedFebruary 10, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1125-2023
Recall Event ID 91483
510(K)NumberK962205 
Product Classification Drape, surgical - Product Code KKX
ProductSurgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Code Information Reorder Number DYNJCD0063, GTIN 40884389462011, Lot # 22GBF090
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
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
FDA Determined
Cause 2
Under Investigation by firm
ActionThe firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "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 return any affected product to you for collection and return to Medline Industries, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."
Quantity in Commerce0 units
DistributionNationwide
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.
510(K) Database510(K)s with Product Code = KKX
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