Baxter Healthcare Corporation recalled 958,351 CLEARLINK CONTINU-FLO IV sets due to a leak risk. The non-vented sets feature three Luer activated valves and a Backcheck Valve. Distribution covered nationwide in the United States. Healthcare providers and patients should stop using the device immediately and follow recall instructions on the recall notice.
IV sets may leak.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions
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IV administration sets are used to deliver fluids and medications via IV lines in medical settings. The CLEARLINK CONTINU-FLO solution set is a non-vented configuration with three valves and a retractable collar.
Leakage in IV sets can compromise fluid delivery and potentially expose patients to IV fluids or medications.
This recall is not indicated as part of a broader industry pattern in the provided data.
Hospitals and clinics distributing these units nationwide may need to replace affected sets to ensure safe IV therapy; 958,351 units were distributed.
FDA recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0193-2026
Typically 4-8 weeks for refunds or replacements
Keep the recall notice, model numbers, date codes, and all correspondence with Baxter or suppliers
Model numbers and product code: 2C8537. UDI/DI 00085412048970. Model numbers include R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024. Sold nationwide in the US through hospitals and medical facilities. Sold since unspecified date. Product Code 2C8537. Price not disclosed.
No injuries or incidents have been reported.
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