The Recall Desk
HighFDA (Devices)·Z-2648-2020·Announced 2020-07-29

Carefusion Safe-T-Centesis 6 Fr Catheter Drainage Tray Recalled for 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 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 criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Carefusion 2200 Inc is recalling the Safe-T-Centesis 6 Fr Catheter Drainage Tray (Catalog: PIG1260T; UDI: 50885403108363). The recall involves specific batches of the product, including 0001319266, 0001320359, and 0001320361, among others listed in the agency record.

The recall is due to a defect where 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 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 distributors should stop using the affected products and contact the recalling firm for instructions on return or replacement. The source text does not specify a particular action for individual consumers, as the product is distributed to institutional customers.

The recalled product

Product
Safe-T-Centesis 6 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 (20)

  • Catalog: PIG1260T
  • UDI: 50885403108363
  • Batches: 0001319266
  • 0001320359
  • 0001320361
  • 0001321495
  • 0001321903
  • 0001322646
  • 0001323766
  • 0001324093
  • 0001324318
  • 0001331342
  • 0001332814
  • 0001332817
  • 0001333972
  • 0001335443
  • 0001335444
  • 0001335695
  • 0001336580
  • 0001336581

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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