The Recall Desk
HighFDA (Devices)·Z-2656-2020·Announced 2020-07-29

Carefusion Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray Recalled

Carefusion 2200 Inc is recalling Safe-T PLUS 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 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, illnesses, or fatalities, aligning with 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 8 Fr Catheter Drainage Tray. The recall was initiated 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 affected product is identified by Catalog Number TPT1000SP and UDI 50885403108431. Specific batch numbers are listed in the official recall documentation. The product was distributed to 370 US customers and 13 distributors across numerous states and territories, including federal distribution channels.

Healthcare facilities and distributors should stop using the affected trays and contact the manufacturer for further instructions. Patients who have received this device should consult their healthcare provider regarding the potential risk of air introduction.

The recalled product

Product
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Catheter / Drainage
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 (19)

  • Catalog: TPT1000SP UDI: 50885403108431
  • Batches: 0001319836
  • 0001320129
  • 0001321726
  • 0001321727
  • 0001322906
  • 0001323275
  • 0001324091
  • 0001324317
  • 0001333308
  • 0001333777
  • 0001334187
  • 0001335697
  • 0001337779
  • 0001337982
  • 0001341544
  • 0001342586
  • 0001344739
  • 0001346286

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 →

Related recalls

Same manufacturer · Carefusion 2200 Inc

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Same hazard · air introduction

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