CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report

Safe-T PLUS Thora-Para Catheter Drainage Tray recalled

Carefusion 2200 is recalling Safe-T PLUS Thora-Para Catheter Drainage Tray, distributed in 46 states. The recall was initiated on 28 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2659-2020
FDA event ID: 85751
Recalling firm: Carefusion 2200, Vernon Hills, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2020
FDA classified: 18 Jul 2020
Reported: 29 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

28 May 2020	Recall initiated by company
18 Jul 2020	Classified by FDA	+51 days
29 Jul 2020	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray

Where it was distributed

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, 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, WY Customer listed, including Federal distribution, uploaded.

Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Is Safe-T PLUS Thora-Para Catheter Drainage Tray recalled?

Yes. Carefusion 2200 recalled Safe-T PLUS Thora-Para Catheter Drainage Tray on 28 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2659-2020.

Why was it recalled?

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Which lots are affected?

Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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