Carefusion Thora-Para Catheter Drainage Tray Recalled for Internal Valve Leaks
Carefusion 2200 Inc is recalling Thora-Para 5 Fr 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 is a risk-of-harm product where injury has not yet been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Carefusion 2200 Inc is recalling the Thora-Para 5 Fr Catheter Drainage Tray (Catalog TPT1005) due to a defect in the Universal Drainage Set (UDS). The UDS may contain valves that leak internally, which may result in the introduction of up to 30cc of air into the patient.
The recall affects 370 US customers and 13 distributors across 48 states and Puerto Rico. Affected batches include 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, and 0001345011. The UDI for the product is 50885403220850.
Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for instructions on return or replacement. Patients who have received this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Thora-Para 5 Fr Catheter Drainage Tray
- Manufacturer
- Carefusion 2200 Inc
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 (7)
- Catalog: TPT1005 UDI: 50885403220850
- Batches: 0001320127
- 0001323274
- 0001333152
- 0001335109
- 0001339556
- 0001345011
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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