Infusion catheters recalled for missing antimicrobial heparin coating
Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device lacking a critical functional feature—the antimicrobial heparin coating—that users relied on based on labeling. The mislabeling creates a risk-of-harm scenario by removing expected infection protection, but no injuries or illnesses have been reported.
Plain-English summary
Medline Industries has recalled CENTURION infusion catheters in five specific lot numbers because they were mislabeled as having an antimicrobial heparin coating when they do not. The affected catheters were either distributed directly or manufactured into medical convenience kits.
The affected product is the CENTURION infusion catheter, 7F, 17cm (Reorder number MIC17F7). A total of 1,200 units were distributed across Florida, Kansas, North Dakota, Pennsylvania, Washington, West Virginia, and Illinois. The affected lot numbers are: 2024103190, 2024050990, 2024021290, 2024012990, and 2024111990.
Without the promised antimicrobial heparin coating, these catheters may not provide the intended protection against catheter-related infection. Healthcare facilities and users who received these catheters should verify they do not have the affected lot numbers. If these catheters were received or used, users should contact Medline Industries with any questions or concerns.
The recalled product
- Product
- CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI/DI 10653160249979 (EA) 20653160249976 (CS)
- Lot Numbers: 2024103190
- 2024050990
- 2024021290
- 2024012990
- 2024111990
Distribution
Part of a larger recall action
This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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