FDA Medical devices recall ·
MEDLINE ARTERIAL LINE PACK recall
- Recall number
- Z-1049-2025
- Date
- (initiated December 23, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50 units
- Hazard tags
- Sterility Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Why was it recalled?
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10195327561543 (ea) 40195327561544 (cs), Lot Numbers: 24IMA276, 24JMI065, 24FMF777, 24GMG420
Distribution
US: FL, KS, ND, PA, WA, WV, IL, WA
States: Florida Illinois Kansas North Dakota Pennsylvania Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1049-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.