Carefusion Thora-Para Catheter Drainage Tray Recalled for Valve Leakage
Carefusion 2200 Inc is recalling Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk of harm (air introduction) where specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Carefusion 2200 Inc is recalling the Thora-Para 5 Fr Non-Valved Catheter Drainage Tray (Catalog: OTP5000). The recall involves specific batches identified by UDI 50885403284746 and batch numbers ranging from 0001319437 to 0001346992.
The recall is issued because the Universal Drainage Set (UDS) may contain valves that leak internally. This defect may result in the introduction of up to 30cc of air into the patient. The agency has classified this recall as Class II.
The product was distributed to 370 US customers and 13 distributors across numerous states, including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Healthcare facilities and distributors should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Thora-Para 5 Fr Non-Valved 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 (20)
- Catalog: OTP5000
- UDI: 50885403284746
- Batches 0001319437
- 0001320128
- 0001321277
- 0001321728
- 0001322907
- 0001324316
- 0001332577
- 0001334404
- 0001335108
- 0001336587
- 0001337314
- 0001338451
- 0001339415
- 0001341205
- 0001342585
- 0001344650
- 0001346669
- 0001346992
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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