Carefusion Safe-T PLUS Thora-Para Catheter Drainage Tray Recalled for Valve Leaks
Carefusion is recalling Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
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: The recall is classified as FDA Class II. The hazard involves the introduction of air into the patient, which poses a risk of harm, but the source text does not report any specific injuries, hospitalizations, or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Carefusion 2200 Inc is recalling the Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray. The recall is due to a defect where the Universal Drainage Set (UDS) may contain valves that leak internally. This malfunction may result in the introduction of up to 30cc of air into the patient.
The affected product is identified by Catalog number OTP5000SP, UDI 50885403284746, and Batch 0001337784. The product was distributed to 370 US customers and 13 distributors across numerous states and territories, including Alabama, Arizona, California, Florida, New York, and Texas, as well as Puerto Rico. A customer list including federal distribution has been uploaded to the agency record.
Healthcare facilities and consumers should stop using the affected catheter drainage trays immediately. Users should contact Carefusion 2200 Inc for instructions on returning the product or obtaining a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
- Manufacturer
- Carefusion 2200 Inc
- Category
- Medical Device — Catheter
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 (3)
- Catalog: OTP5000SP
- UDI: 50885403284746
- Batch 0001337784
Distribution
Part of a larger recall action
This product is one of 14 recalled by Carefusion 2200 Inc 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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