CLASS II ONGOING Device recall · Reported 24 Feb 2021 · FDA Enforcement Report

Gambro Cartridge Blood Set Prime Line, product recalled

Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line. The recall was initiated on 30 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 07332414007836, All lots within expiry

Quantity recalled7437480 units

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-1118-2021
FDA event ID: 87150
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 30 Dec 2020
FDA classified: 16 Feb 2021
Reported: 24 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Dec 2020	Recall initiated by company
16 Feb 2021	Classified by FDA	+48 days
24 Feb 2021	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

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Product as listed by the FDA

Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

Which lots are affected?

UDI 07332414007836, All lots within expiry

Where was it sold?

Worldwide distribution.

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

5 other products · FDA event 87150

This product is part of a recall event; the main page for the event is Gambro Cartridge Blood Transport System recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
24 Feb 2021	CLASS II	Gambro Cartridge Blood Transport System recalled by Baxter Healthcare	Baxter Healthcare	Other	IL
24 Feb 2021	CLASS II	Gambro Cartridge Blood Transport System recalled by Baxter Healthcare	Baxter Healthcare	Other	IL
24 Feb 2021	CLASS II	Gambro Cartridge Low Volume Blood Transport System recalled	Baxter Healthcare	Other	IL
24 Feb 2021	CLASS II	Gambro Cartridge Low Weight-Low Volume Blood Transport recalled	Baxter Healthcare	Other	IL
24 Feb 2021	CLASS II	Gambro Cartridge Single Needle Conversion Kit, product recalled	Baxter Healthcare	Other	IL

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