Medline arterial line catheter packs recalled for missing heparin coating
Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.
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 FDA Class II recall involves a missing safety feature on medical catheters—the antimicrobial heparin coating—creating a risk-of-harm situation. No illnesses or injuries have been reported, but the potential for infection without the antimicrobial coating justifies a High severity classification.
Plain-English summary
Medline Industries, LP is recalling certain lots of Sterile Infusion Catheters included in MEDLINE ARTERIAL LINE PACK kits (REF DYNJ65208B) that were mislabeled as having antimicrobial heparin coating when they do not have this coating. The affected catheters were either distributed directly or manufactured into medical convenience kits and distributed.
Affected lot numbers include: 24IMA276, 24JMI065, 24FMF777, and 24GMG420. The product was distributed to locations in Florida, Kansas, North Dakota, Pennsylvania, Washington, West Virginia, and Illinois. The antimicrobial heparin coating is a specified feature of these catheters, and its absence may increase infection risk during clinical use.
The recalled product
- Product
- MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 50
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 (5)
- UDI/DI 10195327561543 (ea) 40195327561544 (cs)
- Lot Numbers: 24IMA276
- 24JMI065
- 24FMF777
- 24GMG420
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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