High FDA (Devices)·Z-2659-2020·Announced 2020-07-29

Carefusion Safe-T PLUS Thora-Para Catheter Drainage Tray Recalled for Valve Leaks

Carefusion 2200 Inc is recalling Safe-T PLUS 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 involves a medical device defect that poses a risk of harm (air introduction) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling the Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray. 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 TPT1005SP, UDI 50885403220867, and Batch 0001345010. 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 consumers who have this product should stop using it and contact Carefusion 2200 Inc for further instructions.

The recalled product

Product: Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Manufacturer: Carefusion 2200 Inc
Category: Medical Device — Catheter / Drainage
Hazard: air-introduction
valve-leak

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: TPT1005SP UDI: 50885403220867
Batch: 0001345010

Distribution

Distributed in 46 states:

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.

See all 14 products in this recall →

Same manufacturer · Carefusion 2200 Inc

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Same hazard · air introduction