The Recall Desk
HighFDA (Devices)·Z-2651-2020·Announced 2020-07-29

Carefusion Safe-T-Centesis Catheter Drainage Tray Recalled for Internal Valve Leaks

Carefusion 2200 Inc is recalling Safe-T-Centesis 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 may introduce air into a patient, representing a risk of harm 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 8 Fr Catheter Drainage Tray (Catalog: PIG1280T) due to a defect in the Universal Drainage Set (UDS). The UDS may contain valves that leak internally, which may result in the introduction of up to 30cc of air into the patient.

The affected product was distributed to 370 US customers and 13 distributors across numerous states and Puerto Rico. Specific batch numbers involved in the recall include 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, and 0001345260.

Healthcare facilities and consumers should check their inventory for the specific catalog and batch numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the internal leak poses a risk of air introduction to the patient.

The recalled product

Product
Safe-T-Centesis 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 (9)

  • Catalog: PIG1280T UDI: 50885403108400
  • Batches: 0001320864
  • 0001321078
  • 0001333781
  • 0001335698
  • 0001336588
  • 0001337539
  • 0001341632
  • 0001345260

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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