Carefusion Thora-Para Catheter Drainage Tray Recalled for Internal Valve Leaks
Carefusion 2200 Inc is recalling Thora-Para 8 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 defect where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.
Plain-English summary
Carefusion 2200 Inc is recalling the Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine. The recall is due to a defect where 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 affected product is identified by Catalog TPT1000CDF, UDI 50885403231900, and Batch 0001333309.
The product was distributed to 370 US customers and 13 distributors across multiple 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 product and contact the recalling firm for instructions.
The recalled product
- Product
- Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
- Manufacturer
- Carefusion 2200 Inc
- Hazard
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)
- Catalog: TPT1000CDF UDI: 50885403231900
- Batch 0001333309
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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