Anesthesia sets recalled because they contain recalled leaking Clearlink IV sets
Medline is recalling 950 Adult Anesthesia Sets because specific lots may contain Clearlink IV sets that Baxter recalled following customer reports of leaking.
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: Scored 3 under the risk-of-harm criterion: the kits carry an IV set recalled for leaking, which can interrupt delivery of fluids or medicines, and no injuries are reported.
Plain-English summary
Medline Adult Anesthesia Sets, REF DYNJ39985G, are being recalled because specific items and lots of the kits may contain Clearlink IV sets, which Baxter recalled due to customer reports of leaking.
The recall covers 950 units carrying UDI/DI 10198459062353 for each unit and 40198459062354 for the case, from lot 25GMB464. The product was distributed in Missouri. The FDA has classified the action as Class II.
The enforcement record traces the problem to the component IV set rather than the rest of the kit, and reports no injuries.
Facilities holding the affected lot should quarantine it and follow Medline's instructions.
The recalled product
- Product
- Medline Adult Anesthesia Set, REF DYNJ39985G
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Anesthesia set
- Affected units
- 950
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
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