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Use caution Medical device recall · FDA · Published June 14, 2019

Bard EQUISTREAM XK Hemodialysis Catheter Recall: Incorrect Peel-Apart Sheath Hazard

Bard recalls EQUISTREAM XK Long-Term Hemodialysis Catheters with incorrect peel-apart introducer sheath. This may cause complications during dialysis procedures. Affected units have specific model and serial numbers.

🇺🇸 FDA recall #Z-2209-2020Medical deviceBard ›
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Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer

What happened, in plain English

Bard is recalling EQUISTREAM XK long-term hemodialysis catheters that contain an incorrect peel-apart introducer sheath. This could lead to complications during dialysis treatments if the sheath is used improperly. Read more at govinfonow.com/recall/67669-bard-equistream-xk-hemodialysis-catheter-recall-incorrect-peel-apart-sheath.

Source Summary by GovInfoNow · govinfonow.com/recall/67669-bard-equistream-xk-hemodialysis-catheter-recall-incorrect-peel-apart-sheath · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2209-2020

Cite this page

“Bard EQUISTREAM XK Hemodialysis Catheter Recall: Incorrect Peel-Apart Sheath Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67669-bard-equistream-xk-hemodialysis-catheter-recall-incorrect-peel-apart-sheath. Based on FDA recall #Z-2209-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2020%22&limit=1).

Why it’s dangerous

The incorrect peel-apart introducer sheath may not function properly during dialysis procedures. This could lead to complications such as blockages or infections if the sheath is not properly secured.

Who’s affected

Hemodialysis patients and healthcare providers who use the recalled EQUISTREAM XK catheters are affected. Patients with the specific model and serial numbers listed in the recall are at risk.

How to tell if you have this one

Check for the model number 'EQUISTREAM XK' with the serial number 'RECT0999' and the specific reference number '5913190/(01)00801741013836'. The catheter is a 16F size.

  • Brand
    Bard
  • Product
    EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Recall numberProduct, codes & lotsQuantity
Z-2208-2020EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F; LOT RECV3572215
Z-2209-2020EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F; RECT0999400
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number, serial number, and reference number on the catheter packaging or label.

Where it went and when

Where it was distributed

Distributed in 24 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Florida, Georgia, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Montana, New York, North Carolina, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 5.3 years after the firm started it.

1. Firm started the recall: Jun 14, 201912. FDA classified it Class II: Jun 2, 202023. Published in FDA’s Enforcement Report: Jun 10, 202034. FDA terminated the recall: Sep 18, 2024420192024
  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-2209-2020 (June 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2209-2020 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