CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

B.Braun Accuflo/H Elastomeric Infusion Device recalled

B. Braun Medical is recalling B.Braun Accuflo/H Elastomeric Infusion Device, distributed in Missouri. The recall was initiated on 6 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 4A1125F111

Quantity recalled8,640 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-2655-2014
FDA event ID: 69054
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2014
FDA classified: 16 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

6 Aug 2014	Recall initiated by company
16 Sep 2014	Classified by FDA	+41 days
24 Sep 2014	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

The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.

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

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

Where it was distributed

Distributed in the state of Missouri.

Missouri

Questions about this recall

Is B.Braun Accuflo/H Elastomeric Infusion Device recalled?

Yes. B. Braun Medical recalled B.Braun Accuflo/H Elastomeric Infusion Device on 6 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2655-2014.

Why was it recalled?

Which lots are affected?

Lot Number: 4A1125F111

Where was it sold?

Distributed in the state of Missouri.

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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