Medline Adult Anesthesia Set recalled for leaking IV component
Medline Industries is recalling Adult Anesthesia Sets containing Clearlink IV Sets that Baxter recalled due to customer reports of leaking. Healthcare facilities should discontinue use of affected sets.
What this means for you
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: FDA Class II medical device recall involving high-risk anesthesia equipment. Although classified as FDA Class II, no illnesses or injuries have been reported. The hazard represents a risk-of-harm scenario for critical medical devices with unconfirmed patient impact, meeting the criterion for High (3) severity.
Plain-English summary
Medline Industries, LP is recalling certain Adult Anesthesia Sets (REF DYNJ39985G, Lot Number 25GMB464) that may contain Clearlink IV Sets. Baxter recalled these IV sets following customer reports of leaking.
Leaking IV sets used in anesthesia equipment could compromise fluid delivery during anesthesia administration. No illnesses or injuries have been reported in connection with this recall.
The recalled anesthesia sets were distributed nationwide, with approximately 950 units affected, primarily in Missouri. Lot Number 25GMB464 is specifically identified in this recall.
Healthcare facilities that received these sets should cease using them and contact Medline Industries, LP for replacement or further guidance.
The recalled product
- Product
- Medline Adult Anesthesia Set, REF DYNJ39985G
- Manufacturer
- Medline Industries, LP
- Hazard
- iv-set-leakage
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 (2)
- UDI/DI 10198459062353 (EA) 40198459062354 (Case)
- Lot Numbers: 25GMB464
Distribution
Distributed nationwide across the United States.
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