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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Procedure Kits

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 Class 2 Device Recall Medline Procedure Kitssee related information
Date Initiated by FirmJanuary 09, 2025
Date PostedFebruary 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1183-2025
Recall Event ID 96188
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Code Information 1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
866-359-1704
Manufacturer Reason
for Recall		Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 1/9/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 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 response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-282-FGX1 Recall Code: Recall Code 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce0 kits
DistributionUS States: CA, NY
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 = LRO
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