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Lower risk Medical device recall · FDA · Published February 12, 2021

Teleflex PLEUR-EV: Sterility Risk in Thoracic Catheters

Teleflex recalls sterile thoracic catheters due to lack of sterility assurance. Affected units may cause infections if used without proper sterility.

🇺🇸 FDA recall #Z-1298-2021Medical deviceTeleflex ›
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Recalling firmTELEFLEX MEDICAL INC3015 Carrington Mill Blvd · Morrisville, NC 27560-5437
✎ GovInfoNow plain-language explainer

What happened, in plain English

Teleflex is recalling sterile thoracic catheters that could be contaminated, risking infections if used. This affects medical procedures where the catheter drains fluid from the chest. Read more at govinfonow.com/recall/63276-teleflex-pleur-ev-sterility-risk-in-thoracic-catheters.

Source Summary by GovInfoNow · govinfonow.com/recall/63276-teleflex-pleur-ev-sterility-risk-in-thoracic-catheters · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1298-2021

Cite this page

“Teleflex PLEUR-EV: Sterility Risk in Thoracic Catheters.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63276-teleflex-pleur-ev-sterility-risk-in-thoracic-catheters. Based on FDA recall #Z-1298-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1298-2021%22&limit=1).

Why it’s dangerous

The catheters lack proper sterility assurance, which could lead to infections if used in medical procedures. This is a risk during drainage of fluid from the chest cavity.

Who’s affected

Healthcare providers using these catheters for medical procedures. Patients undergoing thoracic drainage treatments are most at risk.

How to tell if you have this one

Check for the catalog number DRAC-32S. Look for manufacturing lot/serial numbers starting with 73J2000276. The product is sold in single-use packaging.

  • Brand
    Teleflex
  • Product
    PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the catalog number DRAC-32S and lot/serial numbers starting with 73J2000276.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee.

Recall timeline

FDA terminated this recall 5.4 years after the firm started it.

1. Firm started the recall: Feb 12, 202112. FDA classified it Class II: Mar 24, 202123. Published in FDA’s Enforcement Report: Mar 31, 202134. FDA terminated the recall: Jul 10, 2026420212026
  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-1298-2021 (February 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1298-2021 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