Carefusion Safe-T-Centesis Catheter Drainage Tray Recalled for Internal Valve Leaks
Carefusion 2200 Inc is recalling Safe-T-Centesis 6 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 scenario where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Carefusion 2200 Inc is recalling the Safe-T-Centesis 6 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 malfunction may result in the introduction of up to 30cc of air into the patient.
The affected product is identified by Catalog number PIG1260TCDF and UDI 50885403231894. The recall covers Batches 0001335833 and 0001341627. 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 customers should stop using the affected trays and contact Carefusion 2200 Inc for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
- 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: PIG1260TCDF UDI: 50885403231894
- Batches 0001335833 and 0001341627
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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