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Lower risk Medical device recall · FDA · Published April 9, 2019

Cook Thoracentesis Set Recall: Small Catheter Hole Risk

Cook recalls Thoracentesis Set RPN C-THS-850 (Lot NS7662071) due to potential small catheter hole causing complications during medical procedures.

🇺🇸 FDA recall #Z-1725-2019Medical deviceCook ›
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Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

Cook is recalling a specific Thoracentesis Set model because it might have a catheter hole that's too small. This could lead to complications during medical procedures like draining fluid from the chest. Affected units were sold with Lot Number NS7662071. Read more at govinfonow.com/recall/68369-cook-thoracentesis-set-recall-small-catheter-hole-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68369-cook-thoracentesis-set-recall-small-catheter-hole-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1725-2019

Cite this page

“Cook Thoracentesis Set Recall: Small Catheter Hole Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68369-cook-thoracentesis-set-recall-small-catheter-hole-risk. Based on FDA recall #Z-1725-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1725-2019%22&limit=1).

The FDA announced on April 9, 2019, that Cook Inc. voluntarily recalled Thoracentesis Set, RPN C-THS-850, because the catheter distal end hole may be too small, GovInfoNow's records show.

How to tell if you have it

  • Brand: Cook
  • Product: Thoracentesis Set, RPN C-THS-850
  • Order #: G03286
  • Lot Number: NS7662071
  • Quantity: 5 units

The hazard

The affected products may have been manufactured with the catheter distal end hole too small, according to the FDA.

Context

GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Transseptal Needle Recall (Oct. 8, 2021). Additional similar recalls include Cook Centimeter Sizing Catheters Recall (April 2, 2026), Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025), and Cook Rupsch-Uchida Liver Access Sets Recall (Nov. 26, 2025).

How to tell if you have this one

Check for the product name 'Thoracentesis Set', model number RPN C-THS-850, and lot number NS7662071 on the packaging or label.

  • Brand
    Cook
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Recall numberProduct, codes & lotsQuantity
Z-1722-2019Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282; Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS770472883 kits
Z-1723-2019Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284; Lot Number NS77260432 kits
Z-1724-2019Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030; Lot Number NS76392802 kits
Z-1725-2019Thoracentesis Set, RPN C-THS-850, Order # G03286; Lot Number NS76620715 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number RPN C-THS-850 and lot number NS7662071 on the product packaging or label.

Where it went and when

Where it was distributed

Distributed in Ohio, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Ohio.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Apr 9, 201912. FDA classified it Class II: Jun 4, 201923. Published in FDA’s Enforcement Report: Jun 12, 201934. FDA terminated the recall: Apr 28, 2020420192020
  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-1725-2019 (April 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1725-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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