CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Equistream¿ XK Long-Term Hemodialysis Catheter recalled

Bard Peripheral Vascular is recalling Equistream¿ XK Long-Term Hemodialysis Catheter, distributed in 24 states. The recall was initiated on 14 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRECT0999

Quantity recalled400

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2209-2020
FDA event ID: 85510
Recalling firm: Bard Peripheral Vascular, Tempe, AZ
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2019
FDA classified: 2 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

14 Jun 2019	Recall initiated by company
2 Jun 2020	Classified by FDA	+354 days
10 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect Peel-Apart Introducer Sheath in Kit.

Product as listed by the FDA

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

Where it was distributed

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.

Alabama Arkansas Arizona California Florida Georgia Iowa Idaho Illinois Kentucky Louisiana Maryland Minnesota Montana North Carolina New York Oregon Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

Incorrect Peel-Apart Introducer Sheath in Kit.

Which lots are affected?

RECT0999

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 85510

Reported	Class	Recall	Company	Reason	Where
10 Jun 2020	CLASS II	Equistream¿ XK Long-Term Hemodialysis Catheter recalled	Bard Peripheral Vascular	Other	24 states

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