CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp recalled

Baxter Healthcare is recalling Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short. The recall was initiated on 7 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers within expiry

Quantity recalled58,194 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-0577-2022
FDA event ID: 89327
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jan 2022
FDA classified: 8 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

7 Jan 2022	Recall initiated by company
8 Feb 2022	Classified by FDA	+32 days
16 Feb 2022	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

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483

Where it was distributed

Worldwide

Questions about this recall

Is Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short recalled?

Yes. Baxter Healthcare recalled Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short on 7 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0577-2022.

Why was it recalled?

Which lots are affected?

All lot numbers within expiry

Where was it sold?

Worldwide

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

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