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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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 Class 2 Device Recall MEDLINEsee related information
Date Initiated by FirmDecember 23, 2024
Date PostedJanuary 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1049-2025
Recall Event ID 96066
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Code Information UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
FDA Determined
Cause 2		Process change control
ActionMedline Industries, LP issued one IMMEDIATE ACTION REQUIRED notice and one MEDICAL DEVICE RECALL notice to its affected consignees on 12/23/2024 via email and US Mail. The IMMEDIATE ACTION REQUIRED notice explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue corrected labeling to affix to the devices. The MEDICAL DEVICE RECALL notice, which pertains to kits manufactured with the affected catheters as a component, also explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue a label to affix to the devices which will state the affected component shall be removed and discarded from further use.
Quantity in Commerce50 units
DistributionUS: FL, KS, ND, PA, WA, WV, IL, WA
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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