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Lower risk Medical device recall · FDA · Published May 28, 2020

Carefusion Safe-T PLUS Thora-Para : Air Leak Risk in Drainage Tray

Carefusion recalls Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray due to potential air leaks from valves, which could introduce up to 30cc of air into patients. Affected units have specific catalog and batch numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2659-2020Medical deviceCarefusion ›
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Contact the company

Recalling firmCarefusion 2200 Inc75 N Fairway Dr · Vernon Hills, IL 60061-1845
✎ GovInfoNow plain-language explainer

Carefusion is recalling Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Trays that may leak air through internal valves, risking up to 30cc of air entering patients. This could cause complications for individuals using medical drainage systems. Read more at govinfonow.com/recall/65071-carefusion-safe-t-plus-thora-para-air-leak-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/65071-carefusion-safe-t-plus-thora-para-air-leak-risk-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2659-2020

Cite this page

“Carefusion Safe-T PLUS Thora-Para : Air Leak Risk in Drainage Tray.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65071-carefusion-safe-t-plus-thora-para-air-leak-risk-in. Based on FDA recall #Z-2659-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2659-2020%22&limit=1).

Carefusion 2200 Inc recalled Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray units due to a potential internal valve leak that may introduce up to 30cc of air into a patient, the FDA said on May 28, 2020.

How to tell if you have it

  • Brand: Carefusion
  • Product: Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
  • Catalog: TPT1005SP
  • UDI: 50885403220867
  • Batch: 0001345010

The hazard

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

Context

GovInfoNow's records show Carefusion 2200 Inc has issued eight other recalls since December 20, 2013. Recent brand recalls include a July 13, 2023 recall for Snowden-Pencer Surgical Dissector cracking risk and a March 16, 2023 recall for Vaginal Specula label mismatch. Other recent recalls of similar products include an ICU Medical Hotline Fluid Warming Set leakage risk (June 24, 2026), an ICU Medical CADD Yellow Medication Cassette Reservoir leakage risk (August 20, 2026), and a Rocket 18Fg Seldinger Catheter Tray falling risk (November 7, 2025).

How to tell if you have this one

Check for the catalog number TPT1005SP and batch number 0001345010 on the tray. The product was sold with these specific identifiers.

  • Brand
    Carefusion
  • Category
    Medical device
FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lots
Z-2646-2020Thora-Para 5 Fr Non-Valved Catheter Drainage Tray; Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992
Z-2647-2020Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray; Catalog: OTP5000SP; UDI: 50885403284746; Batch 0001337784
Z-2648-2020Safe-T-Centesis 6 Fr Catheter Drainage Tray; Catalog: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480
Z-2649-2020Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine; Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627
Z-2650-2020Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray; Catalog: PIG1260TSP UDI: 50885403108387; Batches: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, 0001346293
Z-2651-2020Safe-T-Centesis 8 Fr Catheter Drainage Tray; Catalog: PIG1280T UDI: 50885403108400; Batches: 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, 0001345260
Z-2652-2020Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray; Catalog: PIG1280TSP UDI: 50885403108424; Batches: 0001320865, 0001321079, 0001333154, 0001333780, 0001335440, 0001338450, 0001341635
Z-2653-2020Thora-Para 8 Fr Catheter Drainage Tray; Catalog: TPT1000 UDI: 50885403108486; Batches: 0001319053, 0001319438, 0001320227, 0001320514, 0001321276, 0001321497, 0001322638, 0001322905, 0001323536, 0001323775, 0001332576, 0001334403, 0001334406, 0001335268, 0001335696, 0001336965, 0001338449, 0001338788, 0001338789, 0001339414, 0001339562, 0001341206, 0001341633, 0001342263, 0001343223, 0001343636, 0001344137, 0001346668, 0001346670, 0001346671
Z-2654-2020Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine; Catalog: TPT1000CDF UDI: 50885403231900; Batch 0001333309
Z-2655-2020Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free; Catalog: TPT1000SDF UDI: 50885403108493; Batches: 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, 0001344740
Z-2656-2020Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray; Catalog: TPT1000SP UDI: 50885403108431; Batches: 0001319836, 0001320129, 0001321726, 0001321727, 0001322906, 0001323275, 0001324091, 0001324317, 0001333308, 0001333777, 0001334187, 0001335697, 0001337779, 0001337982, 0001341544, 0001342586, 0001344739, 0001346286
Z-2657-2020Thora-Para 5 Fr Catheter Drainage Tray; Catalog: TPT1005 UDI: 50885403220850; Batches: 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, 0001345011
Z-2658-2020Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free; Catalog: TPT1005SDF UDI: 50885403228139; Batches: 0001333153 and 0001339557
Z-2659-2020Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray; Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010
Based on the official FDA remedy

What to do — step by step

  1. Check Tray Details

    Look for the catalog number TPT1005SP and batch number 0001345010 on the drainage tray.

Where it went and when

Where it was distributed

Distributed in 45 states and Puerto Rico.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: not listedMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 4.3 years after the firm started it.

1. Firm started the recall: May 28, 202012. FDA classified it Class II: Jul 18, 202023. Published in FDA’s Enforcement Report: Jul 29, 202034. FDA terminated the recall: Sep 20, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2659-2020 (May 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2659-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA