Medline Arterial Line Pack (Medline) – Mislabeling (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420
Products Sold
UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420
MEDLINE INDUSTRIES, LP Northfield is recalling MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter wi due to Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical conveni. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Recommended Action
Per FDA guidance
Medline 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, IL, KS, ND, PA, WA, WV
Page updated: Jan 10, 2026