Carefusion Safe-T Thora-Para Tray Recalled for Internal Valve Leakage
Carefusion 2200 Inc is recalling Safe-T 5 Fr Thora-Para 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 and involves a risk of air embolism (introduction of air into the patient), which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Carefusion 2200 Inc is recalling the Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free. The recall is due to a defect where the Universal Drainage Set (UDS) may contain valves that leak internally. This leakage may result in the introduction of up to 30cc of air into the patient.
The affected product is identified by Catalog number TPT1005SDF and UDI 50885403228139. The specific batches involved are 0001333153 and 0001339557. The product was distributed to 370 US customers and 13 distributors across numerous states and territories, 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 customers should stop using the affected trays and contact Carefusion 2200 Inc for instructions on return or replacement. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
- 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 (2)
- Catalog: TPT1005SDF UDI: 50885403228139
- Batches: 0001333153 and 0001339557
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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