Z-2657-2020Class II

Thora-Para 5 Fr Catheter Drainage Tray

Name: Z-2657-2020 Thora-Para 5 Fr Catheter Drainage Tray
Creator: Carefusion 2200 Inc
Published: 2020-05-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-05-28 / Terminated

FDA source

Carefusion 2200 Inc began a recall of Thora-Para 5 Fr Catheter Drainage Tray on 2020-05-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2657-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-28
Posted: 2020-07-20
Terminated: 2024-09-20
Recalling firm: Medtronic, Inc.
Product: Thora-Para 5 Fr Catheter Drainage Tray
Product code: PXI Thoracentesis Tray
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.
FDA root cause: Under Investigation by firm
Action: All affected consignees are being notified via FedEx mailed letter and/or email beginning 6/15/2020. BD requests a sub-recall to be conducted if product has been further distributed. Consignees are asked to complete the acknowledgement form included with the notification letter and return to BD.
Distribution: 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.
Product codes and lots: Catalog: TPT1005 UDI: 50885403220850; Batches: 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, 0001345011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2657-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2646-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2647-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2648-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2649-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2650-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2651-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2652-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2653-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2654-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2655-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2656-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2657-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2658-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18
Z-2659-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-18

Product code PXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)