CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Safeline Y-Type Blood Set recalled by B. Braun Medical

B. Braun Medical is recalling Safeline Y-Type Blood Set, distributed nationwide in the US. The recall was initiated on 20 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 2024

Quantity recalled3,300 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-0940-2020
FDA event ID: 84365
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2019
FDA classified: 1 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

20 Nov 2019	Recall initiated by company
1 Feb 2020	Classified by FDA	+73 days
12 Feb 2020	Published in enforcement report	+11 days

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

Reason for recall

Potential for leakage at the joint between the blood filters and tubing

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

Safeline Y-Type Blood Set, Catalog Number NF5140

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Is Safeline Y-Type Blood Set recalled?

Yes. B. Braun Medical recalled Safeline Y-Type Blood Set on 20 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0940-2020.

Why was it recalled?

Potential for leakage at the joint between the blood filters and tubing

Which lots are affected?

GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 2024

Where was it sold?

US Nationwide

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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